[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Murdoch Childrens Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":710},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,42,78,104,130,169,194,217,254,300,328,357,384,411,438,459,486,512,542,566,589,615,638,664,685],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100645078","bandicoot-an-adaptive-platform-trial-to-improve-health-outcomes-after-paediatric-stem-cell-transplant-100645078",false,"NCT07679100","BANDICOOT: An Adaptive Platform Trial to Improve Health Outcomes After Paediatric Stem Cell Transplant","BANDICOOT: An Adaptive Platform Trial Designed to Improve the Complications, Cost-effectiveness and Health Outcomes for Children Receiving a Stem Cell Transplant","BANDICOOT","Inclusion Criteria:\n\n* Aged \\>1 week to ≤ 18 years old\n* The participant is intending to receive or will be eligible for allogeneic HSCT within the next 4 months.\n\nExclusion Criteria:\n\n* Death is deemed to be imminent and inevitable AND one or more of the participant or parent\u002Fsubstitute decision maker, or attending physician are not committed to full active treatment\n* A suitable donor for HCT is not identified.\n\nEach domain may have additional, domain-specific eligibility criteria. The additional eligibility criteria that are specific to a domain will be provided in each domain-specific Study Record, linked to this Master record. Participants who fulfil the BANDICOOT Platform Eligibility Criteria will be assessed for enrolment into all domains that are active at their trial site.","ALL","1 Week","18 Years",{"count":22,"type":23},10000,"ESTIMATED","INTERVENTIONAL",[26],"NA","Background: In children with \\>120 rare diseases, haematopoietic stem cell transplant (HSCT) provides a medical \"reset\" for the body, replacing diseased or dysfunctional bone marrow with healthy donor-derived stem cells following high-dose chemotherapy and\u002For radiotherapy. However, severe and fatal complications are common with HSCT. There has been a lack of properly conducted clinical trials to decrease mortality and morbidity. Traditional randomised controlled trials (RCTs) have several critical limitations in children undergoing HSCT, including population heterogeneity, restrictive eligibility criteria and slow enrolment. Adaptive platform trials (APTs) may overcome these limitations through enhanced trial efficiency by sharing a control group, reducing sample size and allowing continuous learning from accumulating data. APTs also allow simultaneous evaluation of distinct interventions at different timepoints and in multiple subgroups of participants, facilitating tailored approaches across heterogeneous populations. When an intervention proves superior, it becomes the new standard of care, allowing additional interventions to be introduced.\n\nTo improve outcomes, we have developed an international APT - BANDICOOT. This trial will continuously enrol children and adolescents receiving HSCT and allow the assessment of multiple novel interventions simultaneously. The goal is to accelerate research findings, reduce duplication of efforts, and improve patient outcomes.\n\nObjectives: The primary objective of BANDICOOT is to determine the effectiveness of a range of interventions to improve HSCT outcomes for children and adolescents.\n\nThe secondary objectives include:\n\n* Assessing the cost-effectiveness of trial interventions\n* Assessing the safety of a range of interventions to improve HCT outcomes\n* Collection of a core data set for participants consenting to the platform regardless of domain eligibility.\n\nStudy design: BANDICOOT is a prospective, pragmatic, adaptive platform trial with interventions organised into domains. Domains may be open-label or blinded.\n\nStudy population: The trial population will be children aged 1-week old to 18 years old who are receiving an HSCT.\n\nTrial outcomes: The primary outcome is an ordinal scale of HSCT outcomes based on organ support, viraemia, immune reconstitution and relapse status censored at Day 100 post HSCT. The selection and grading of components within this ordinal endpoint was informed by a formal endpoint development process, described in detail by Walker et al, 2025 (see References).\n\nInterventions: Multiple interventions will be evaluated in BANDICOOT across multiple treatment modalities (domains). New interventions will be added over time, and interventions may be dropped for futility or included in standard care as the study progresses. The details of the interventions will be provided in separate clinicaltrials.gov Study Records, linked to this Master record.\n\nAbbreviated methods: Inferences in this trial will be based on a Bayesian statistical model. The primary outcome will be analysed using a multinomial model with a cumulative logistic link, which is an extension of a binary logistic model to account for ordinal outcomes with more than two categories, and is commonly known as the 'proportional odds' model. Secondary outcomes will be analysed with parametric models specific to the type of outcome (e.g., the Bernoulli model with a logistic link for binary endpoints).",[29],"Haematopoietic Stem Cell Transplant, Allogeneic","NOT_YET_RECRUITING","2026-06-25",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":23},"2027-03",{"date":38,"type":23},"2047-12",{"name":40,"class":41},"Murdoch Childrens Research Institute","OTHER",{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":24,"phases":54,"briefSummary":56,"conditions":57,"keywords":64,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100644540","phase-3-tranexamic-acid-to-reduce-blood-loss-after-varus-derotation-osteotomy-100644540","NCT07672158","Tranexamic Acid to Reduce Blood Loss After Varus Derotation Osteotomy","Postoperative Continuous Intravenous Tranexamic Acid Infusion to Reduce Blood Loss in Non-Ambulatory Children With Cerebral Palsy Following Bilateral Bony Hip Reconstructive Surgery: A Phase III Parallel-Group Randomised Placebo-Controlled Trial","TABLO","Inclusion Criteria:\n\n* Children (aged 4 to 16 years)\n* Diagnosis of cerebral palsy (CP). CP is an umbrella term under which many specific diagnoses are captured, and the clinical team at the study institution operates a comprehensive referral network to ensure patients with any relevant diagnoses are included.\n* Gross Motor Function Classification System (GMFCS) levels IV and V, with substantial hip displacement (\\>40% migration percentage per Australian Hip Surveillance Guidelines (Wynter M, Gibson N, Kentish M, Love S, Thomason P, Willoughby K, et al. Australian hip surveillance guidelines for children with cerebral palsy 2014. Australian Academy of Cerebral Palsy and Developmental Medicine. 2014.)), who are on the waitlist for bilateral proximal femoral varus derotational osteotomy (VDRO) +\u002F- unilateral or bilateral pelvic osteotomy.\n\nExclusion Criteria:\n\n* Haematological disorder (defined as an active genetic or acquired bleeding disorder)\n* Known hypersensitivity to tranexamic acid (TXA)\n* Children with promyelocytic leukaemia being treated with oral tretinoin will be excluded from the trial because combination with TXA has resulted in fatal thrombotic complications\n* Known coagulation defect\n* Known renal disorder (moderate to severe as per study institution guidelines)","4 Years","16 Years",{"count":53,"type":23},52,[55],"PHASE3","TABLO (Tranexamic Acid to reduce Blood Loss after varus derotation Osteotomy) is a clinical trial of postoperative tranexamic acid vs placebo in non-ambulatory children with cerebral palsy (CP) undergoing reconstructive hip surgery.\n\nImproving surgical outcomes is a high priority in this patient population given the high risk of bleeding and the diminished capacity for these children to withstand substantial blood loss. Preliminary data from the study institution indicates that approximately one third of these patients receive transfusion of blood products in the postoperative period. There is growing evidence that hidden blood loss occurring in the postoperative period is substantial and can potentially be attenuated with the administration of Tranexamic Acid (TXA). However, trials on postoperative TXA have been carried out exclusively in adult surgical populations.",[58,59,60,61,62,63],"Cerebral Palsy","Hip Surgery Corrective","Tranexamic Acid Use","Blood Loss, Surgical","Paediatrics","Orthopedics",[58,65,66,67,68],"Hip surgery","Tranexamic Acid","Blood Loss","Orthopaedics","2026-06-23",{"date":71,"type":34},"2026-06-26",{"date":73,"type":23},"2026-07",{"date":75,"type":23},"2029-04",{"name":40,"class":41},1,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":20,"enrollmentInfo":87,"targetDuration":4,"studyType":24,"phases":89,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":77},"100609061","describing-the-effect-of-familiar-song-on-arousal-and-awareness-for-children-with-disorders-of-consciousness-doc-100609061","NCT07209657","Describing the Effect of Familiar Song on Arousal and Awareness for Children With Disorders of Consciousness (DoC)","A Parallel Mixed Methods Investigation of a Music Interventions in Paediatric Disorders of Consciousness (DoC)","SongDoC","Inclusion Criteria:\n\n* Diagnosis of a severe ABI, as indicated by at least one of the following:\n\n  * Glasgow Coma Scale (GCS) 3-8 at admission to RCH\n  * Mass pathology evident on neuroimaging\n  * Expert opinion of treating consultant\n* Diagnosis of a DoC, as indicated by at least one of the following:\n\n  * Rancho Los Amigos Scale I, II, III or IV\n  * Expert opinion of treating consultant\n* Legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. Interpreters will be employed as necessary.\n\nExclusion Criteria:\n\n* ABI not compatible with life\u002Fchild expected to die\n* ABI resulting from suspected non-accidental causes, including assault\u002Fabuse\n* Diagnosed premorbid or acquired severe hearing loss\n* Inability or unwillingness of legally acceptable representative to give written informed consent","1 Year",{"count":88,"type":23},10,[26],"The goal of this clinical trial is to compare the effect of live music therapy and recorded music on recovery of consciousness in children aged 1 to 18 years who have a disorder of consciousness (DoC) after a severe brain injury. Researchers also want to learn how children respond during music and noise, whether early responses to music are linked to recovery at 6 months, and how parents experience music therapy during their child's hospital stay at The Royal Children's Hospital (RCH) in Melbourne.\n\nParticipants will:\n\n* Take part in a 10-day study period while in hospital. On 8 of the 10 days, they will receive either live or recorded familiar music in random order. Their level of consciousness will be measured before and after each session using a simple behavioural checklist. On the other 2 days, they will take part in video-recorded sessions to compare behavioural responses during live music, recorded music, and white noise. Videos will help capture small changes in movement, eye gaze, or facial expression.\n* Have their level of consciousness checked again at 6 months after injury to see if early responses relate to later recovery.\n\nParents and caregivers will be invited to take part in an interview about their experiences and observations of music therapy with their child.\n\nThis study will help researchers understand whether live music therapy provides benefits beyond recorded music and will guide how music therapy is best used to support children and families during recovery from severe brain injury.",[92,93],"Disorder of Consciousness","Acquired Brain Injury",[95,96,97],"music therapy","music","paediatric disorder of consciousness",{"date":31,"type":34},{"date":100,"type":23},"2026-08",{"date":102,"type":23},"2028-11-30",{"name":40,"class":41},{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":18,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":24,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100600740","speed-of-lung-inflation-during-ventilation-of-extremely-preterm-infants-100600740","NCT07101419","Speed of Lung Inflation During Ventilation of Extremely Preterm Infants","Longer Pressure Rise Time During Mechanical Ventilation of Extremely Preterm Infants: A Randomised Crossover Trial","FLOW-VENT","Inclusion Criteria:\n\n* Admitted to participating neonatal intensive care unit\n* Born between 22+0 to 27+6 weeks' gestation\n* Current weight ≥400 grams\n* Receiving synchronised, patient-triggered, volume-targeted (all breaths) conventional mechanical ventilation (Pressure Control-Assist Control + Volume Guarantee \\[PC-AC+VG\\] mode on Dräger Babylog VN500\u002F800 ventilators) initiated within 72-hours post birth\n* Postnatal age ≥6 hours and ≤7 days\n* Received surfactant therapy\n* Clinically stable (as per treating and research team consensus)\n* Parent(s)\u002Flegal guardian provides prospective informed consent.\n\nExclusion Criteria:\n\n* Major congenital anomaly involving the cardiac, respiratory or gastrointestinal systems, or a known genetic syndrome or diagnosis that might affect respiratory course and outcomes\n* Severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 22 weeks in which the neonatal consultant anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life\n* Receiving (or expected to receive within the next 12 hours) any other mode of mechanical ventilation including synchronised intermittent mandatory ventilation (SIMV), pressure support ventilation (PSV) or high-frequency oscillatory ventilation\n* Planned for extubation from mechanical ventilation within the next 12 hours.","6 Hours","7 Days",{"count":115,"type":23},68,[26],"Babies born extremely preterm (\\\u003C28 weeks of pregnancy) require support to breathe. Some babies require help to breathe from a breathing machine (mechanical ventilator). While this keeps babies alive, it may damage their lungs. To reduce this damage, doctors and nurses take particular care to try and provide the gentlest breathing support possible. However, evidence is still required to determine how to best support babies' breathing, whilst preventing lung damage and longer-term lung problems.\n\nThis clinical trial aims to compare two ways of adjusting a common setting on the breathing machine. This setting is called the pressure rise time or PRT. The PRT determines how quickly the breathing machine inflates a premature baby's lungs. A short PRT quickly inflates the lungs. A long PRT inflates the lungs more slowly. Previous research suggests that more slowly inflating the baby's lungs may cause less lung damage and still allow oxygen to be delivered to and carbon dioxide to be cleared from the lungs. However, larger studies are required to determine whether this should become the standard treatment.\n\nThis study investigates whether inflating the baby's lungs more slowly (long PRT) using the breathing machine is as effective as the PRT setting currently used (short PRT, more quickly inflating the lungs).\n\nThe main question it aims to answer is: Does how quickly the breathing machine inflates an extremely preterm baby's lung impact their oxygen levels?",[119,120],"Respiratory Distress Syndrome, Newborn","Respiratory Distress Syndrome in Premature Infant","2026-06-21",{"date":123,"type":34},"2026-06-24",{"date":125,"type":23},"2027-02",{"date":127,"type":23},"2028-02",{"name":40,"class":41},3,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":18,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":24,"phases":142,"briefSummary":143,"conditions":144,"keywords":155,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":168,"locationsCount":77},"100604558","tag-team---trans-adolescent-group-therapy-100604558","NCT07151079","TAG TEAM - Trans Adolescent Group Therapy","Evaluation of Trans Adolescent Group ThErapy for Alleviating Minority Stress (TAG TEAM): a Randomised Controlled Trial","TAG TEAM","Participants will be enrolled into the RCT only if they meet all the inclusion criteria and none of the exclusion criteria.\n\nInclusion Criteria:\n\n* Identifies as trans, non-binary, or gender diverse\n* Is between the ages of 12 and 17 years inclusive\n* Has completed primary school at the time of enrolment into the study\n* Has current psychological stress symptomology as determined by a score of moderate or above on the DASS-Y\n* Provide informed consent: All participants and parent\u002Flegal guardians must be willing to give informed consent\n\nExclusion Criteria:\n\n* Has current acute suicidal symptomology as determined by a combination of clinical judgement and the results of the Ask Suicide-Screening Questions (ASQ) suicide screening tool (e.g., answer yes to question 5) to determine the risk of suicide (has an active plan and\u002For intent to suicide) at time of screening interview\n* Is actively having treatment with any other group psychological intervention at the time of enrolment into the study\n* Is not proficient in English (as the group Cognitive behaviour therapy (CBT) program will be delivered in English and funds aren't available for interpreters)\n* Previous participation in the feasibility trial\n* Is currently enrolled in tertiary study (e.g., undergraduate university)","12 Years","17 Years",{"count":141,"type":23},142,[26],"This project will study the effect of the TAG TEAM group CBT program on the mental health of trans and gender diverse adolescents. TAG TEAM was co-designed by researchers and clinicians with a group of trans and gender diverse young people to help trans and gender diverse adolescents understand and cope with minority stress. Minority stress includes experiences like discrimination and rejection. TAG TEAM focuses on learning and practicing skills to support mental health and wellbeing. It also includes group discussions and activities with other trans and gender diverse young people. TAG TEAM groups are run by a psychologist and a trans peer facilitator. A trans peer facilitator is a trans and gender diverse person who is there to share their experience of being trans and to support participants in the group sessions.",[145,146,147,148,149,150,151,152,153,154],"Minority Stress","Acceptability","Psychological Distress","Anxiety","Depression in Adolescence","Coping","Wellbeing","Pride","Internalised Stigma","Community Connection",[156,157,158,151,159,160],"Adolescent","Trans and gender diverse","Minority stress","Group Therapy","CBT","RECRUITING","2026-06-04",{"date":164,"type":34},"2026-06-05",{"date":166,"type":34},"2026-05-21",{"date":36,"type":23},{"name":40,"class":41},{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":18,"minAge":176,"maxAge":138,"enrollmentInfo":177,"targetDuration":4,"studyType":24,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":77},"100595948","using-a-speech-generating-device-to-support-communication-in-rare-genetic-conditions-100595948","NCT07039084","Using a Speech-Generating Device to Support Communication in Rare Genetic Conditions","A Randomized Cross-over Trial Examining the Efficacy of Implementing a Speech-generating Device for Rare Genetic Conditions","Inclusion Criteria:\n\n* Is between the ages of 3 and 12 years, inclusive, at the time of enrolment\n* Has a diagnosis of a rare genetic disorder\n* Passes a visual-motor screening test, therefore being able to tap on an iPad spontaneously or by imitation and has adequate hearing\n* Considered \"minimally verbal\" with less than 50 spontaneous words (or gestalts) at baseline assessments, confirmed with the LVIS.\n* Is not currently using a speech-generating device with proficiency (i.e. using the device as a main mode of communication on a daily basis).\n* Is English-speaking or consents to therapy being conducted in English (parents will need to be able to complete the parent-reported measures in English)\n\nExclusion Criteria:\n\n* Has an additional or dual genetic variation (as this is likely to cause multiple complications and increase variability),\n* Is extremely ill or has progressed into a later stage of their disease (i.e. child has clinically significant loss of vision, hearing, fine motor skills, or is unable to adequately attend sessions due to illness),\n* This is to ensure treatment is beneficial, reduce harm and reduce attrition rates.\n* Lives outside of the state of Victoria (making it difficult for in-person appointments)\n* Inability or unwillingness of participant or legally acceptable representative to give written informed consent.","3 Years",{"count":178,"type":23},38,[26],"Individuals with rare genetic conditions may experience a delay or loss of developmental skills. Many have limited verbal speech. The aim of this clinical trial is to examine how well a speech-generating device supports the communication skills of participants with a rare genetic condition. The speech-generating device is a communication program loaded onto an iPad.\n\nThis is a crossover trial, meaning that each participant will receive both the treatment (device) and a control (usual care; no device) phase. The order in which each participant receives the device versus the usual care (no device) will depend on which group the participant is assigned to. The changes in communication in each phase will then be compared.\n\nDuring the trial, participants can expect to complete a series of assessments and attend a total of 2 x 1-hour therapy session per week for 6 weeks.",[182,183,184,185,186],"Genetic Disease","Nonverbal Communication","Augmentative and Alternative Communication","Rare Genetic Disease","Rare Genetic Disorders",{"date":188,"type":34},"2026-05-26",{"date":190,"type":34},"2025-11-03",{"date":192,"type":23},"2027-05",{"name":40,"class":41},{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":202,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":24,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},"100612300","optimising-breathing-support-at-extubation-in-very-preterm-infants-a-clinical-study-100612300","NCT07251790","Optimising Breathing Support at Extubation in Very Preterm Infants: A Clinical Study","PrePAP: Pre-Extubation Continuous Positive Airway Pressure in Very Preterm Infants: A Randomised Controlled Trial","PrePAP","Inclusion Criteria:\n\n* The infant is admitted to participating NICU\n* The infant is born between 22+0 to 29+6 weeks gestational age\n* The infant has been on a form of invasive mechanical ventilation for at least 4 hours\n* The infant is being electively extubated for the first time from invasive mechanical ventilation to nCPAP\n* The infant is clinically stable (as per clinical and research team consensus)\n* The parent(s) or legal guardian(s) provides prospective informed consent.\n\nExclusion Criteria:\n\n* The infant is born \\\u003C22 weeks or \\>30 weeks gestational age\n* The infant has a major congenital anomaly involving the cardiac, respiratory or gastrointestinal systems, or a known genetic syndrome or diagnosis that might affect respiratory course and outcomes\n* The infant has severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 22 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life\n* The infant is receiving invasive mechanical ventilation via nasotracheal intubation\n* The infant is planned for extubation to any other mode of non-invasive respiratory support than nCPAP, or no respiratory support\n* Refusal of informed consent from the parent(s), or the infant does not have a guardian who can provide informed consent.","0 Hours",{"count":204,"type":23},134,[26],"Many babies born very preterm (\\\u003C32 weeks of pregnancy) require support to breathe from a breathing machine (mechanical ventilator) via a breathing tube. Although this keeps babies alive, it can damage their lungs. To reduce this damage, doctors and nurses try to change babies to gentler breathing support that does not require a breathing tube. This is usually done using a method called nasal continuous positive airway pressure (nCPAP) that uses a nosepiece to deliver breaths. This process of removing the breathing tube is called \"extubation\". Many babies will need the breathing tube put back in after extubation (for various reasons) and this is independently associated with poorer outcomes.\n\nThis research study aims to compare two ways of performing extubation - both of which are already used regularly by doctors and nurses. The \"standard extubation\" approach involves taking a baby's breathing tube out first, then applying the nosepiece and starting nCPAP. The more recent approach, called \"prePAP\", involves applying the nosepiece and starting nCPAP before taking the breathing tube out. Previous research suggests that a prePAP approach may provide better support for babies during extubation. However, larger studies are required before this approach is more commonly used.\n\nThis study is investigating whether extubating the baby with prePAP is better than extubating the baby without prePAP.\n\nThe main question it aims to answer is: Does initiating nCPAP before extubation in very preterm babies reduce the fall in their oxygen levels post-extubation?",[119,120],"2026-05-17",{"date":210,"type":34},"2026-05-19",{"date":212,"type":34},"2026-05-04",{"date":214,"type":23},"2028-03-31",{"name":40,"class":41},2,{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":225,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":24,"phases":228,"briefSummary":229,"conditions":230,"keywords":237,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":253,"locationsCount":77},"100603443","sos-for-caregiver-wellbeing-100603443","NCT07136584","SOS for Caregiver Wellbeing","SOS for Caregiver Wellbeing: Testing the Feasibility of a Screening, Outcomes and Support (SOS) Model for Parents and Caregivers of Children With Chronic Conditions","SOS","Inclusion Criteria:\n\n* must be a parent of a child \\\u003C18yo in an outpatient clinic at Royal Children's Hospital (in enrolled clinics either neuromuscular or diabetes)\n* able to complete a consent form in English without an interpreter\n\nExclusion Criteria:\n\n* need for an interpreter to complete informed consent",true,{"count":227,"type":23},100,[26],"Parents and caregivers of children who have a chronic condition carry a large care burden and are at higher risk of having mental health symptoms. This study aims to see if completion of a mental health questionnaire by parents \u002F caregivers at or before the child's paediatric appointment can help identify any symptoms of stress, anxiety or depression.\n\nFollowing the questionnaire, parents \u002F caregivers will be provided with the results of the questionnaire along with an information resource sheet. This will include information on anxiety, stress and depression, as well as different agencies they can contact to get support.\n\nParents \u002F caregivers will be followed up at 3 and 6 months to see if they have any changes to mental health and quality of life, and whether they accessed any support services. Participants who did not complete the 3-month survey will be asked at the 6-month clinic visit to provide responses on an iPad to up to 5 questions selected from the 3-month survey. A text message will be sent prior to the visit to inform them.\n\nThe primary aim for this trial is to see whether parents \u002F caregivers find this process acceptable, and whether it can work in a busy hospital clinic.",[231,232,233,234,235,236],"Mental Health","Depression and Burden in Caregivers","Anxiety Depression","Stress","Caregiver Anxiety","Parent of Child With Chronic Life-threatening Illness",[238,239,240,241,242,243,244,245,246],"parent","caregiver","chronic illness","screening","mental health","anxiety","depression","stress","referral pathways","2026-05-07",{"date":249,"type":34},"2026-05-12",{"date":251,"type":34},"2025-10-22",{"date":100,"type":23},{"name":40,"class":41},{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":18,"minAge":262,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":24,"phases":265,"briefSummary":267,"conditions":268,"keywords":287,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":299,"locationsCount":216},"100514796","phase-2-a-trial-of-targeted-therapies-for-patients-with-slow-flow-or-fast-flow-vascular-malformations-100514796","NCT05983159","A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations","A Modular Open Label, Signal Seeking, Phase II Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations (TARGET-VM)","TARGET-VM","MODULE 1\n\nInclusion Criteria:\n\n1. Adult or paediatric patient, 2 years of age or over\n2. Patient has a clinical diagnosis of a slow-flow vascular malformation\n3. Patient has received standard therapy for the vascular malformation or in which, in the opinion of the investigator, standard therapy is not appropriate\n\n   \\- Note: standard therapy may include treatment with sirolimus. A minimum of 14 days since the last dose of sirolimus is required prior to starting treatment with alpelisib\n4. A documented genetic alteration in the PI3K signalling pathway identified by genetic sequencing prior to enrolment in this study\n5. Adequate performance status (Eastern Cooperative Oncology Group Performance Status Scale (ECOG) 0-2 in patients ≥ 16 years of age; Lansky \\> 50 in patients \\\u003C 16 years of age)\n6. Patient has a life expectancy ≥ 12 weeks\n7. Patient is able to swallow and retain oral medication\n8. Adequate haematologic and end-organ function:\n\n   * Haematology: Haemoglobin ≥ 9.0 g\u002FdL; Absolute neutrophil count ≥ 1.5 x 109\u002FL; Platelets ≥ 90 x 109\u002FL, except where bleeding leading to low haemoglobin level is an indication for treatment, in which case haemoglobin \\\u003C 9.0 g\u002FdL is acceptable.\n   * Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AT) ≤ 3 x ULN; Total bilirubin \\\u003C 2x ULN except for participants with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN\n   * Renal function: Serum creatinine \\\u003C 1.5 x ULN\n   * Biochemistry: Calcium (corrected for serum albumin) and magnesium within normal limits or ≤ Grade 1 according to NCI-CTCAE v5.0 if judged clinically not significant by the investigator; Potassium within normal limits, or corrected with supplements\n   * Fasting blood glucose ≤ 7.0 mmol\u002FL and Glycosylated Haemoglobin (HbA1c) ≤ 6.4% (both criteria must be met)\n9. Patient agrees to abstinence or highly effective contraceptive measures for males and women of childbearing potential (WOCBP)\n\n   * Males who are sexually active must use a condom during intercourse while taking alpelisib and for at least 4 weeks after stopping alpelisib and should not father a child in this period. A condom is required to be used also by vasectomised men in order to prevent delivery of the drug via seminal fluid. In addition, male participants must not donate sperm during the study and for at least 4 weeks after stopping alpelisib\n   * Females who are of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use a highly effective method of contraception during study treatment and for at least 1 week after the last dose of any study treatment. Highly effective contraceptive methods include:\n\n     * Total abstinence (when this is in line with the preferred and usual lifestyle of the subject) Periodic abstinence (eg., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;\n     * Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the women has been confirmed by follow up hormone level assessment;\n     * Male partner sterilisation (at least 6 months prior to screening) of the sole partner of a female participant on the study;\n     * Use of oral (estrogen and progesterone), injected or implanted combined hormonal method of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormonal vaginal ring or transdermal hormone contraception. In the case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n   * Women are considered postmenopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhoea with an appropriate clinical profile (i.e., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered to be not of child bearing potential.\n10. Patient has signed informed consent and is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations\n\nExclusion Criteria:\n\n1. History of hypersensitivity to any drugs or metabolites of PI3K inhibitors or any of the excipients of alpelisib\n2. Severe infection requiring intravenous antibiotics within 4 weeks prior to enrolment\n3. Patient has had a major surgical procedure within 4 weeks prior to enrolment\n4. Prior use of an alpha-specific PI3K inhibitor\n5. History of pneumonitis or interstitial lung disease\n6. Patient is pregnant or lactating at the time of study registration. A pregnancy test is mandated for women of child-bearing potential in the screening period\n7. Established diagnosis of type I diabetes mellitus, type II diabetes mellitus requiring anti-hyperglycaemic medication or any participant with HbA1c \\> 6.4%\n8. Patient who is currently receiving medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes\n9. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to the start of treatment:\n\n   * Strong inducers of CYP3A4\n   * Strong inhibitors of CYP3A4\n   * Inhibitors of BCRP\n10. History of acute pancreatitis within 1 year of screening or past history of chronic pancreatitis\n11. Patient with Child Pugh score B or C\n12. Unresolved osteonecrosis of the jaw\n13. Impairment of GI function or GI disease that may significantly alter the absorption of the study drug based on investigator discretion\n14. Known history of Human Immunodeficiency Virus (HIV) infection (testing for HIV is not mandatory in screening)\n15. Known history of severe cutaneous reactions like Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Erythema Multiforme (EM), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)\n16. Known history of clinically significant, uncontrolled heart disease and\u002For recent cardiac events including:\n\n    * History of angina pectoris, coronary artery bypass graft (CABG), symptomatic pericarditis, or myocardial infarction within 6 months prior to the start of study treatment;\n    * History of documented congestive heart failure (New York Heart Association functional classification III-IV);\n    * History of impaired Left Ventricular Ejection Fraction (LVEF) \\\u003C 50% (an assessment of LVEF is not mandatory in screening)\n    * History of clinically significant cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle branch block, high grade Atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II and third degree AV block without pacemaker in place);\n    * Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mmHg and\u002For Diastolic Blood Pressure (DBP) ≥ 100 mmHg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening;\n    * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or corrected QT interval \\> 470 msec at screening (using Fridericia correction);\n    * Bradycardia (heart rate \\\u003C 50 beats per minute at rest), by electrocardiogram (ECG) or pulse\n17. Patient has other concurrent severe and\u002For uncontrolled medical conditions that would, in the Treating Physician's judgement, contraindicate administration of alpelisib (eg. active or uncontrolled severe infection, chronic active hepatitis, immune-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure)\n18. Patient is unable to understand and comply with treatment instructions and requirements\n\nMODULE 2\n\nInclusion Criteria:\n\n1. Adult or paediatric patient, 2 years of age or over where Body Surface Area (BSA) is greater than or equal to 0.4m2.\n2. Patient has a clinical diagnosis of a fast-flow vascular malformation\n3. Patient has received standard therapy for the vascular malformation or in which, in the opinion of the investigator, standard therapy is not appropriate\n\n   \\- Note: standard therapy may include treatment with sirolimus. A minimum of 14 days since the last dose of sirolimus is required prior to starting treatment with mirdametinib\n4. A documented genetic alteration in the RAS-MEK-ERK signalling pathway identified by genetic sequencing prior to enrolment in this study\n5. Adequate performance status (Eastern Cooperative Oncology Group Performance Status Scale (ECOG) 0-2 in patients ≥ 16 years of age; Lansky \\> 50 in patients \\\u003C 16 years of age)\n6. Patient has a life expectancy ≥ 12 weeks\n7. Participant has the ability to swallow capsules whole if the capsule dosage form is being utilized. This criterion does not apply if participant is utilizing the dispersible tablet form of study treatment\n8. Adequate haematologic and end-organ function:\n\n   * Haematology: Haemoglobin ≥ 9.0 g\u002FdL; Absolute neutrophil count ≥ 1.5 x 109\u002FL; Platelets ≥ 90 x 109\u002FL, except where bleeding leading to low haemoglobin level is an indication for treatment, in which case haemoglobin \\\u003C 9.0 g\u002FdL is acceptable.\n   * Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AT) ≤ 2 x upper limit of normal (ULN); Total bilirubin \\\u003C 1.5x ULN (isolated bilirubin \\> 1.5x ULN is acceptable if bilirubin is fractioned and direct bilirubin \\\u003C 35%), except where impaired hepatic function is a consequence of the fast-flow malformation and hence is an indication for treatment, in which case impaired hepatic function is acceptable.\n   * Renal function: Serum creatinine \\\u003C 1.5 x ULN\n   * Biochemistry: Calcium (corrected for serum albumin) and magnesium within normal limits or ≤ Grade 1 according to NCI-CTCAE v5.0 if judged clinically not significant by the investigator; Potassium within normal limits or corrected with supplements; Phosphate ≤ 1x ULN.\n9. Patient agrees to abstinence or highly effective contraceptive measures if of childbearing potential (WOCBP)\n\n   * Males who are sexually active must use a condom during intercourse while taking mirdametinib and for at least 90 days after stopping mirdametinib and should not father a child in this period. A condom is required to be used also by vasectomised men in order to prevent delivery of the drug via seminal fluid. In addition, male participants must not donate sperm during the study and for at least 90 days after stopping mirdametinib\n   * Females who are of child-bearing potential, defined as all individuals physiologically capable of becoming pregnant, must use a highly effective method of contraception during study treatment and for at least 180 days after the last dose of any study treatment. Highly effective contraceptive methods include:\n\n     * Total abstinence (when this is in line with the preferred and usual lifestyle of the subject) Periodic abstinence (eg., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;\n     * Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the women has been confirmed by follow up hormone level assessment;\n     * Male partner sterilisation (at least 6 months prior to screening) of the sole partner of a female participant on the study;\n     * Use of oral (estrogen and progesterone), injected or implanted combined hormonal method of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormonal vaginal ring or transdermal hormone contraception. In the case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n   * Women are considered postmenopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhoea with an appropriate clinical profile (i.e., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered to be not of childbearing potential.\n10. Patient has signed informed consent and is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations\n\nExclusion Criteria:\n\n1. History of hypersensitivity to any drugs or metabolites of MEK inhibitors or any of the excipients of mirdametinib\n2. Severe infection requiring intravenous antibiotics within 4 weeks prior to enrolment\n3. Patient has had a major surgical procedure within 4 weeks prior to enrolment\n4. Prior use of a MEK inhibitor\n5. Patient has abnormal QT interval corrected by Fridericia's formula (\\> 450 msec for male participants, \\> 470 msec for female participants, or \\> 480 msec for participants with bundle branch block) (triplicate ECG readings taken approximately 2 to 3 minutes apart and averaged) at Screening;\n6. Patient is pregnant or lactating at the time of study registration. A pregnancy test is mandated for persons of child-bearing potential in the screening period\n7. Impairment of GI function or GI disease that may significantly alter the absorption of the study drug based on investigator discretion\n8. Any clinically significant active or known history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)\n9. Lymphoma, leukaemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years;\n10. Breast cancer within the past 5 years;\n11. Known history of Human Immunodeficiency Virus (HIV) infection (testing for HIV is not mandatory in screening)\n12. Known history of severe cutaneous reactions like Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Erythema Multiforme (EM), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)\n13. Patient has a history of, or evidence of, retinal pathology on ophthalmologic examination that is considered a risk factor for central serous retinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration. Patients will be excluded from study participation if they have any of the following risk factors for RVO at Screening:\n\n    * Intraocular pressure \\> 21 mmHg;\n    * Serum cholesterol \\> 7.8 mmol\u002FL;\n    * Serum triglycerides \\> 3.4 mmol\u002FL;\n    * Hyperglycaemia (fasting blood glucose \\> 7.0 mol\u002FL );\n    * Age specific hypertension\n\n      * Patients ≥ 13 years of age with a blood pressure ≥ 140\u002F90 mmHg\n      * Patients ≤ 12 years of age with a blood pressure ≥ 95th percentile for age + 12 mmHg\n14. Known history of glaucoma\n15. Known history of clinically significant, uncontrolled heart disease and\u002For recent (within 6 months \\[24 weeks\\] of signing informed consent\u002Fassent) cardiac events including:\n\n    * History of angina pectoris, coronary artery bypass graft (CABG), symptomatic pericarditis, or myocardial infarction within 6 months prior to the start of study treatment;\n    * History of documented congestive heart failure (New York Heart Association functional classification III-IV);\n    * History of clinically significant cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle branch block, high grade Atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II and third degree AV block without pacemaker in place);\n    * Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 140 mmHg and\u002For Diastolic Blood Pressure (DBP) ≥ 90 mmHg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening;\n    * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or corrected QT interval \\> 470 msec at screening (using Fridericia correction);\n    * Bradycardia (heart rate \\\u003C 50 beats per minute at rest), by electrocardiogram (ECG) or pulse\n16. Patient has recorded a left ventricular ejection fraction (LVEF) \\\u003C 55% at Screening\n17. Patient has experienced a cerebrovascular accident, transient ischaemic attach, or symptomatic pulmonary embolism within 6 months (24 weeks) of signing informed consent\u002Fassent.\n18. Patient has other concurrent severe and\u002For uncontrolled medical conditions that would, in the Treating Physician's judgement, contraindicate administration of mirdametinib (eg. active or uncontrolled severe infection, chronic active hepatitis, immune-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure)\n19. Patient is unable to understand and comply with treatment instructions and requirements","2 Years",{"count":264,"type":23},50,[266],"PHASE2","Recent studies have demonstrated that growth of vascular malformations can be driven by genetic variants in one of 2 signalling pathways. Targeted drugs specific to these pathways have been developed and shown to be effective in treating cancer. This study will describe the effectiveness of (i) 48 weeks of alpelisib therapy for participants with slow-flow vascular malformations and a gene mutation in one of these signalling pathways (module 1) and (ii) 48 weeks of mirdametinib therapy for participants with fast-flow vascular malformations and a gene mutations in the other signalling pathway (module 2).",[269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286],"Slow-Flow Vascular Malformation","Fast-Flow Vascular Malformation","Vascular Malformations","Venous Malformation","Lymphatic Malformation, Low Flow","Lymphatic Malformation","Lymphangioma","Arteriovenous Malformations","Venous Malformation, Low Flow","Cystic Hygroma","Vascular Anomaly","Vascular Anomalies","PI3K Gene Mutation","MAP2K1 Gene Mutation","PIK3CA-related Overgrowth Spectrum","Arteriovenous Malformation (AVM)","KRAS G12C","KRAS G12D",[288,289,290,291,292],"Targeted therapy","vascular malformations","skin diseases, vascular","Phosphatidylinositol 3-Kinases","MEK inhibitor 1","2026-04-29",{"date":295,"type":34},"2026-05-05",{"date":297,"type":34},"2024-09-13",{"date":192,"type":23},{"name":40,"class":41},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":18,"minAge":308,"maxAge":309,"enrollmentInfo":310,"targetDuration":4,"studyType":24,"phases":312,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":327},"100498466","phase-4-improving-therapeutic-drug-monitoring-and-dosing-for-vancomycin-in-young-infants-with-infections-vancapp-part-2-100498466","NCT05770622","Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2)","The VANcomycin Cohort Study - Assessing Precise Dosing and Prompt Drug Monitoring to Improve Attainment of Target Concentrations (Part 2)","VANCAPP","Inclusion Criteria:\n\n* Infants aged 0 - 90 days old\n* Suspected infection requiring treatment with vancomycin for 48 hours or more (as determined by the clinical team)\n\nExclusion Criteria:\n\n* Infants with a corrected gestational age of less than 25 weeks\n* Infants weighing less than 500g.\n* Known allergy to any glycopeptide antibiotic\n* Vancomycin administered within the previous 72 hours\n* Infants receiving any form of extracorporeal life support\n* Renal impairment","0 Days","90 Days",{"count":311,"type":23},40,[313],"PHASE4","A challenge to intermittent vancomycin dosing in young infants is the avoidable delay caused by the need to wait until steady state (i.e. when the drug concentrations are in equilibrium) to measure a vancomycin concentration, as this generally occurs 24 to 48 hours after starting treatment. If the target concentration is not achieved, the dose needs to be adjusted, resulting in further delays in an infant achieving the concentration required to treat their infection. The purpose of this study is to assess the use of early therapeutic drug monitoring (first-dose trough) and, if needed, early dose adjustment, in achieving target vancomycin concentrations at steady state. A dose adjustment calculator (available through a web application) will be used to determine the need for dose adjustment (based on predicted steady state concentration) and recommend an adjusted dose if required.",[316,317,318],"Sepsis","Infections","Bacteremia","2026-04-15",{"date":321,"type":34},"2026-04-20",{"date":323,"type":34},"2024-11-10",{"date":325,"type":23},"2027-04",{"name":40,"class":41},4,{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":139,"enrollmentInfo":336,"targetDuration":4,"studyType":24,"phases":338,"briefSummary":339,"conditions":340,"keywords":345,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":77},"100633919","phase-4-clinical-efficacy-of-stopping-oral-antibiotics-when-symptoms-stop-compared-to-finishing-the-course-100633919","NCT07532941","Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course'","StopStop@HITH - Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course', for Children With Bacterial Infections Through Hospital-in-the-Home (HITH): a Basket Randomised Controlled Trial (RCT)","StopStop@HITH","Inclusion Criteria:\n\n1. Between the ages of ≥ 1 years and ≤ 17 years at enrolment\n2. Diagnosis of cellulitis, urinary tract infection (UTI), lower respiratory tract infection (LRTI) or lymphadenitis\n3. Prescription of oral antibiotics as a switch from IV antibiotics\n\nExclusion Criteria:\n\n1. Clinician determined need for \\>10-day oral antibiotic course\n2. Child with immunosuppression (e.g. as a result of cancer treatment)\n3. Second episode of same bacterial infection within the last 28 days\n4. Child is unable to take oral antibiotics\n5. Previous enrolment in StopStop@HITH\n6. Parent\u002Fguardian does not speak English\n7. Clinician determined need for 10-day course of oral antibiotics for treatment\u002Fclearance of streptococcal infection\n8. UTI only: known impaired renal function (e.g. renal transplant patients or known chronic renal failure)\n9. LRTI only: known chronic respiratory condition (e.g. cystic fibrosis or bronchiectasis) or need for long term respiratory support (e.g. home oxygen, Continuous Positive Airway Pressure \\[CPAP\\] or tracheostomy); empyema or lung abscess",{"count":337,"type":23},200,[313],"The aim of the StopStop@HITH study is to see if stopping antibiotics when symptoms stop is as good as finishing the course of antibiotics. The study will enrol children at the Royal Children's Hospital who are prescribed oral antibiotics after completing a course of intravenous (IV) antibiotics for the treatment of cellulitis, urinary tract infection (UTI), lower respiratory tract infection (LRTI) and lymphadenitis.\n\nThe aims of the study are:\n\n* To determine if oral antibiotics can be safely stopped once symptoms stop in children with cellulitis (who have completed a course of IV antibiotics).\n* To assess feasibility of a larger study of other common infections across multiple hospitals.\n\nThe participants parent\u002Fguardian will complete a daily symptom tracker for the duration of the prescribed oral antibiotic course and attend a telehealth appointment with the study team once the participants symptoms have resolved. There are additional follow up surveys at day 14, day 28 and day 180.",[341,342,343,344],"Urinary Tract Infection","Cellulitis","Respiratory Tract Infections","Lymphadenitis",[346,347,62,348],"Infection","Antibiotics","Symptom Guided","2026-04-08",{"date":351,"type":34},"2026-04-16",{"date":353,"type":23},"2026-06",{"date":355,"type":23},"2028-06",{"name":40,"class":41},{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":18,"minAge":365,"maxAge":366,"enrollmentInfo":367,"targetDuration":4,"studyType":24,"phases":369,"briefSummary":370,"conditions":371,"keywords":373,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":77},"100633104","demistify-the-impact-of-ventilator-pressure-levels-during-minimally-invasive-surfactant-therapy-on-lung-aeration-in-preterm-infants-100633104","NCT07522346","deMISTify: The Impact of Ventilator Pressure Levels During Minimally Invasive Surfactant Therapy on Lung Aeration in Preterm Infants","deMISTify: The Impact of CPAP Levels During Minimally Invasive Surfactant Therapy on Regional Patterns of Ventilation in Preterm Infants","deMISTify","Inclusion Criteria:\n\n* Born between 24 to 31+6 weeks' gestation, by best obstetric estimate\n* Admitted to a participating NICU\n* A parent\u002Fguardian who can provide informed consent\n* Receiving CPAP respiratory support\n* Planned to receive MIST by clinicians as standard clinical care\n* Clinically stable (as determined by clinical team)\n* Infant less than 72 hours of age\n* MIST can be administered within 90 min of allocating assigned interventional arm\n\nExclusion Criteria:\n\n* Receiving any form of respiratory support other than CPAP\n* Receiving more than 8 cmH2O PEEP via CPAP in the 4 hours prior to surfactant administration (except in the Delivery Room as part of resuscitation at birth)\n* The infant's clinical team has concern regarding clinical stability and tolerability of EIT\n* The infant's skin integrity will not tolerate the EIT belt and gel\n* Refusal of informed consent by their parent\u002Fguardian\u002Flegally acceptable representative\n* The infant does not have a parent\u002Fguardian who can provide informed consent.\n* Major congenital anomaly involving the cardiac, respiratory, gastrointestinal systems, or a known genetic syndrome or diagnosis that might affect respiratory course and outcomes\n* Severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 24 weeks in which the neonatal clinician anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early post-natal life\n* Suspected or confirmed air leak or pneumothorax\n* Previous treatment with surfactant or mechanical ventilation via an endotracheal tube\n* Urgent need for intubation and mechanical ventilation as determined by the treating clinician\n* Not receiving full active intensive care (i.e. palliative\u002Fcomfort care)","24 Weeks","32 Weeks",{"count":368,"type":23},36,[26],"Infants born preterm (before 36 weeks' gestation age) have immature lungs and struggle to breathe on their own. They are supported via respiratory machines like ventilators, as well as pharmaceutical aids like surfactant replacement therapy. Surfactant replacement therapy is an established therapy for the treatment of respiratory distress syndrome, which is a common illness in infants born preterm.\n\nSurfactant replacement therapy can be delivered to an infant's lungs a few ways, including via a small tube that is briefly placed down an infant's throat. This is considered the least invasive method currently available, and is becoming more popular. It is referred to as minimally invasive surfactant therapy (MIST). A baby can receive surfactant via MIST if they are receiving non-invasive respiratory support, like from a continuous positive airway pressure (CPAP) machine.\n\nDoctors and researchers are looking for simple ways to make MIST more effective. This clinical trial will investigate if briefly increasing the air pressure delivered by a CPAP machine before giving MIST therapy will make MIST more effective. This strategy is called a lung recruitment manoeuvre (LRM), because it opens up more of the lungs - 'recruits' them - to help with oxygenation. The CPAP setting that is briefly changed is called positive end expiratory pressure (PEEP) - it increases the amount of air left in the lungs at the end of a breath. This stops parts of the lung collapsing when exhaling, which commonly occurs in the lungs of infants born preterm as they are immature.\n\nThe goal of this clinical trial is to investigate if a LRM prior to MIST improves ventilation and lung aeration in preterm infants born 24-32 weeks' gestation. The main question it aims to answer is: How a LRM prior to MIST might impact patterns of ventilation and lung aeration in preterm infants, compared to no LRM prior to MIST.\n\nThe current standard of care is no LRM before MIST. Researchers will compare this current standard against a LRM before MIST to see if it potentially improves patterns of ventilation.\n\nParticipants will be randomly placed (by chance) to receive either no LRM before MIST (control) or a LRM before MIST (intervention). Participants will be randomised once their treating clinical team have decided to give MIST.",[372],"Surfactant Deficiency Syndrome Neonatal",[374,375,376],"Minimally Invasive Surfactant Therapy","Lung Recruitment Manoeuvre","Electrical Impedance Tomography",{"date":378,"type":34},"2026-04-13",{"date":380,"type":23},"2026-04",{"date":382,"type":23},"2028-04",{"name":40,"class":41},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":18,"minAge":392,"maxAge":139,"enrollmentInfo":393,"targetDuration":4,"studyType":24,"phases":395,"briefSummary":396,"conditions":397,"keywords":400,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":77},"100617952","physical-activity-and-exercise-during-early-treatment-phases-for-childhood-acute-lymphoblastic-leukaemia-to-protect-against-muscle-loss-and-improve-frailty-outcomes-100617952","NCT07325305","Physical Activity and Exercise During Early Treatment Phases for Childhood Acute Lymphoblastic Leukaemia to Protect Against Muscle Loss and Improve Frailty Outcomes","The PROTECT Trial Physical Activity and Exercise During Early Treatment for Children With Acute Lymphoblastic Leukaemia to Protect Against Sarcopenia and Improve Frailty Outcomes: a Pilot Randomised Controlled Trial","PROTECT","Inclusion Criteria:\n\n* Aged 5-17 years at the time of consent\n* New diagnosis of acute lymphoblastic leukaemia \\\u003C7 days\n* Is planned to receive management for their cancer treatment at the trial site for the duration of the trial period\n* Has a legally acceptable representative capable of understanding the informed consent document in English and providing consent on the participant's behalf\n* Have a family electronic device that can be linked with the tool to be used (Fitbit)\n\nExclusion Criteria:\n\n* none","5 Years",{"count":394,"type":23},60,[26],"This is a small trial testing out a new approach before doing a bigger study. Researchers are observing a group of children\u002Fadolescents (ages 5-17) with acute lymphoblastic leukemia (ALL) and testing a physical activity and exercise program on a group of them who after 5 weeks of treatment show signs of weakness or frailty.\n\nKids who are NOT losing muscle aren't part of the exercise trial - they're just monitored over time to see how they do.\n\nThe goal:\n\nTo see if an exercise program helps kids who are getting weaker from acute lymphoblastic leukemia treatment build back\u002Fmaintain their strength, compared to kids who don't do the extra intervention. The study will also look at if this way of measuring muscle weakness works well for kids with cancer.",[398,399],"Sarcopenia","Acute Lymphoblastic Leukemia",[401,402,403,404],"exercise","physical activity","behaviour change","paediatrics",{"date":378,"type":34},{"date":407,"type":34},"2026-02-24",{"date":409,"type":23},"2028-10",{"name":40,"class":41},{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":225,"sex":18,"minAge":418,"maxAge":419,"enrollmentInfo":420,"targetDuration":4,"studyType":24,"phases":422,"briefSummary":423,"conditions":424,"keywords":426,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":77},"100565826","using-artificial-intelligence-to-screen-for-hip-dysplasia-100565826","NCT06647225","Using Artificial Intelligence to Screen for Hip Dysplasia","Artificial Intelligence Augmented Ultrasound for Developmental Dysplasia of the Hip: a Validity Study","Inclusion Criteria:\n\n* Enrolled in the VicHip study\n* Is 4-20 weeks of age at enrolment\n* Is attending The Royal Children's Hospital for the purpose of the potential diagnosis of DDH\n* Has a diagnostic (standard) hip ultrasound on the day of their out-patient appointment\n* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.\n\nExclusion Criteria:\n\nParticipants will be excluded from enrolment if:\n\n• They are currently receiving treatment for DDH","4 Weeks","20 Weeks",{"count":421,"type":23},240,[26],"The goal of this clinical trial is to learn if an ultrasound scan using artificial intelligence can accurately screen for hip dysplasia. Researchers will compare the artificial intelligence ultrasound results to the standard ultrasound measures to see if the artificial intelligence ultrasound scan can accurately screen for hip dysplasia.\n\nIt will also seek to understand how parents feel about their children undergoing this scan.\n\nParticipants will:\n\n* Have an additional ultrasound performed on their child at their scheduled outpatient's appointment for hip dysplasia\n* Complete a short questionnaire about the experience of having the measurement performed on their child",[425],"Developmental Dysplasia of Hip",[427,428,429,241,430],"hip dysplasia","artificial intelligence","ultrasound","infants","2026-04-02",{"date":349,"type":34},{"date":434,"type":34},"2024-12-06",{"date":436,"type":23},"2026-11",{"name":40,"class":41},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":18,"minAge":445,"maxAge":20,"enrollmentInfo":446,"targetDuration":4,"studyType":24,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":458},"100560257","phase-2-individualised-dose-optimisation-of-ganciclovir-in-immunocompromised-children-trial-id-magic-100560257","NCT06574789","Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)","ID-MAGIC","Inclusion Criteria:\n\n1. Immunocompromised patients including transplant recipients (haematopoietic stem cell transplant (HSCT), solid organ transplant (SOT)), those receiving chemotherapy or other immunosuppression or those with a known\u002Fsuspected inborn error of immunity (determined by an immunologist); and\n2. Detectable clinically significant CMV viraemia and treating clinician determines that antiviral therapy is indicated.\n3. Willing to partake in the trial\n4. Willing\u002Fable to attend all follow up visits and capable of completing all trial assessments.\n5. Legally acceptable parent\u002Fguardian capable of providing consent on the participant's behalf.\n6. Treating clinician agreeable to child being enrolled in the trial.\n\nExclusion Criteria:\n\n1. Current or prior CMV infection with documented genotypic resistance to GCV (UL97 and\u002For UL54); or\n2. Severe renal impairment (defined as estimated glomerular filtration rate (eGFR) \\\u003C25mL\u002Fmin); or\n3. Congenital CMV infection; or\n4. Life expectancy of less than 7 days as determined by the treating physician; or\n5. History of allergy, or adverse reaction to GCV, aciclovir or any component of the formulation; or\n6. Treating clinician determines that combination antiviral therapy is indicated for CMV infection; or\n7. Has received \\>3 days of IV GCV or foscarnet or oral valganciclovir for the treatment of CMV infection prior to enrolment; or\n8. Prior enrolment in the trial; or\n9. Current recipient of another investigational product used for the treatment of CMV infection, as part of a clinical trial.","1 Month",{"count":447,"type":23},232,[266],"This study is being conducted at seven major children's hospitals in Australia and New Zealand to test a new approach for treating a virus, called cytomegalovirus in children with weakened immune systems. The researchers want to find out if using a web app to customise the dose of a medication called ganciclovir is better at clearing the virus over a six-week period compared to the standard method of giving the medication.",[451],"Cytomegalovirus Viraemia",{"date":349,"type":34},{"date":454,"type":34},"2024-10-29",{"date":456,"type":23},"2028-12",{"name":40,"class":41},7,{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":24,"phases":467,"briefSummary":468,"conditions":469,"keywords":473,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":129},"100588015","phase-4-jack-jumper-ant-venom-immunotherapy-long-term-effectiveness-investigation-100588015","NCT06935890","Jack Jumper Ant Venom Immunotherapy Long-term Effectiveness Investigation","JAVELIN","Eligibility criteria\n\n\\- Any adult (≥ 18 years) who has completed a JJA VIT program at one of the three participating sites.\n\nInclusion Criteria:\n\n1. Completed a continuous program of JJA VIT of between 3 and \\\u003C 6 years duration.\n2. Have ceased JJA VIT for ≥ 18 months but \\\u003C 5 years.\n3. Have the ability to provide informed consent.\n\nExclusion Criteria:\n\n1. Any person \\\u003C 18 years.\n2. Any adult (≥ 18 years) who has not completed a continuous JJA VIT program of duration between 3 and \\\u003C 6 years.\n3. Any adult (≥ 18 years) who has completed a continuous JJA VIT program of duration between 3 and \\\u003C 6 years but ceased JJA VIT \\\u003C 18 months or \\> 5 years ago.\n4. Any person who has a medical condition, that in the opinion of the investigator, may place them at increased risk if they were to have a sting challenge.\n5. Unable to understand study requirements and provide informed consent.",{"count":227,"type":23},[313],"Jack Jumper ant (JJA) venom allergy is a uniquely Australian medical condition. It is the leading cause of venom allergy and affects up to three per cent of the population. 70 percent of people with JJA allergy will have another reaction on a repeat sting and this sensitivity appears to persist for many years.\n\nVenom immunotherapy (VIT) has been shown to be a safe and effective treatment in the prevention of severe systemic allergic reactions (anaphylaxis) to future stings. It is currently offered to patients as standard care in Tasmania, South Australia and Victoria. However, whilst JJA VIT has been used for many years, there is a lack of evidence on the long-term benefit of the treatment and how it impacts patient quality of life.\n\nThis trial will offer patients who have completed a JJA VIT program (between 3 and \\\u003C 6-years duration) and have been off-treatment for at least 18-months and \\\u003C 5 years, to have a supervised JJA sting challenge and blood test to assess their JJA venom tolerance level. It will also ask them to complete a set of questionnaires at different timepoints to obtain a history of their exposure and reactions to JJA stings outside of the hospital setting (field stings), and to measure the impact of the completed VIT and knowledge of their sting challenge outcome on their quality of life and their behaviours around auto-injectors.\n\nThese measures will be used to explore the long-term effectiveness of JJA VIT and the impact of a sting challenge post VIT on a patient's quality of life.",[470,471,472],"Allergy","Immunotherapy","Venom Allergy",[474,475,476,477],"Jack Jumper Ant","Venom Immunotherapy","Sting challenge","VIT","2026-03-29",{"date":480,"type":34},"2026-03-31",{"date":482,"type":34},"2025-11-25",{"date":484,"type":23},"2029-10",{"name":40,"class":41},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":20,"enrollmentInfo":494,"targetDuration":4,"studyType":24,"phases":496,"briefSummary":497,"conditions":498,"keywords":500,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":77},"100556778","phase-4-utilising-genotype-informed-bayesian-dosing-of-tacrolimus-in-children-post-solid-organ-transplantation-100556778","NCT06529536","Utilising Genotype Informed Bayesian Dosing of Tacrolimus in Children Post Solid Organ Transplantation.","Genotype Informed Bayesian Dosing of Tacrolimus in Solid Organ Transplant- Pharmacogenomic Implementation in Children","BRUNO-PIC","Participants will be assigned to the prospective arm if treated at Royal Children's Hospital who are receiving a solid organ transplant (SOT) (excluding repeat graft in liver transplant recipients, or lung or intestinal transplant) and who will be on tacrolimus as one of the main immunosuppressants post-transplant.\n\nInclusion Criteria:\n\n* Age 1-18 years of age\n* Kidney, liver or heart transplant recipients\n* Participant and\u002For parent consent to the study (prospective arm only)\n\nExclusion Criteria:\n\n* Previous liver transplant.\n* Lung OR Intestinal transplant.\n* Insufficient time before transplant for pharmacogenomic analysis (prospective arm only)\n* Immunosuppressant regimen not containing tacrolimus immediate release product\n* Known hypersensitivity to tacrolimus and\u002For its formulation.",{"count":495,"type":23},45,[313],"This study aims to evaluate the efficacy of genotype-informed Bayesian dosing of tacrolimus in optimising drug exposure among paediatric solid organ transplant recipients. By tailoring tacrolimus dosage based on individual genetic makeup and using Bayesian modeling to predict drug levels, the researchers hope to increase the likelihood of achieving therapeutic drug concentrations while minimising the risk of adverse events associated with subtherapeutic or supratherapeutic exposure.",[499],"Solid Organ Transplant",[501,502,503,62],"Tacrolimus","Pharmacogenomics","Bayesian","2026-02-22",{"date":506,"type":34},"2026-02-25",{"date":508,"type":34},"2024-08-05",{"date":510,"type":23},"2027-08-02",{"name":40,"class":41},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":521,"phases":4,"briefSummary":522,"conditions":523,"keywords":527,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":541},"100529110","health-systems-and-policy-contexts-of-medical-oxygen-100529110","NCT06169514","Health Systems and Policy Contexts of Medical Oxygen","Understanding the Health Systems and Policy Contexts of Medical Oxygen in Africa and Asia (MOXY-HSP)","MOXY-HSP","Key informants will be selected representing government, non-governmental agencies, professional associations, private sector, and civil society.",{"count":77,"type":23},"OBSERVATIONAL","This is a mixed-methods program evaluation from a health systems and policy perspective, involving (i) stakeholder analysis, (ii) policy-implementation gap analysis, and (iii) comparative country case studies. This study aims to understand how national oxygen strategies achieve impact at national, and subnational level, across country contexts, at what cost.\n\nThe the investigators seek to:\n\n1. Involve policymakers, implementers (including private sector), and medical oxygen users in identifying challenges and understanding potential solutions to medical oxygen access;\n2. Generate new data on how medical oxygen systems work and can be improved from multiple perspectives;\n3. Draw lessons on medical oxygen that can directly inform national and global practice and policy.\n\nThis study will be conducted in 6 of the 9 countries participating in the Clinton Health Access Initiative (CHAI) led Medical Oxygen Implementation (MOXY) program (Uganda, Nigeria, Rwanda, Liberia, Lao PDR, Cambodia).\n\nKey informants will be selected representing government, non-governmental agencies, professional associations, private sector, and civil society. This study will be completed over 4 years, with timelines varying between country study sites.",[524,525,526],"Hypoxemia","Morality","Pneumonia",[528,529,530,531,532],"Health system","Oxygen","Oxygen systems","Oxygen access","Pulse oximetry","2026-02-04",{"date":535,"type":34},"2026-02-06",{"date":537,"type":34},"2024-07-31",{"date":539,"type":23},"2027-12",{"name":40,"class":41},6,{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":521,"phases":4,"briefSummary":552,"conditions":553,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":77},"100620558","a-long-term-observational-follow-up-study-of-children-and-young-people-who-underwent-an-18-month-course-of-oral-immunotherapy-treatment-for-peanut-egg-or-milk-allergy-5-15-years-post-treatment-100620558","NCT07359183","A Long Term, Observational Follow-Up Study of Children and Young People Who Underwent an 18-Month Course of Oral Immunotherapy Treatment for Peanut, Egg or Milk Allergy (5-15 Years Post-Treatment)","Long Term Outcomes Associated With Attainment of Remission Following Oral Immunotherapy to Peanut, Egg and Cow's Milk (LPEM Study)","LPEM","Inclusion Criteria:\n\n* Previous participant of PEAT, PrEMO, PPOIT-001 or PPOIT-002 parent study\n* Received at least one dose of OIT treatment in the parent study\n* Written informed consent from participant and\u002For parent\u002Fguardian (if below 18 years of age)\n\nExclusion Criteria:\n\n-Have any conditions that, in the opinion of the investigator, precludes participation for reason of safety",{"count":551,"type":23},147,"The goal of this observational study is to learn about the long-term outcomes of children and young people who underwent an 18-month course of oral immunotherapy (OIT) treatment for peanut, egg or milk allergy. It aims to:\n\n• Compare long-term changes in health-related quality of life (HRQL) at 5-15 years after stopping OIT in participants who achieved remission and those who did not.\n\nParticipants will attend a single follow-up visit for:\n\n* A blood test\n* Skin prick test (SPT)\n* Allergy questionnaires",[554,555,556,557],"Food Allergies","Peanut Allergies","Egg Allergy","Milk Allergy","2026-01-29",{"date":560,"type":34},"2026-02-02",{"date":562,"type":34},"2026-01-13",{"date":564,"type":23},"2027-01",{"name":40,"class":41},{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":18,"minAge":573,"maxAge":574,"enrollmentInfo":575,"targetDuration":4,"studyType":24,"phases":576,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":77},"100486539","phase-1-pilot-study-of-mc-in-paediatric-palliative-care-100486539","NCT05615389","Pilot Study of MC in Paediatric Palliative Care","A Pilot Study of Medicinal Cannabis in Paediatric Patients Undergoing Palliative Care for Non-oncological Conditions","Inclusion Criteria:\n\n1. Males and females aged 6 months to 21 years of age;\n2. Receiving care in the Victorian Paediatric Palliative Care Program for a non-oncological condition;\n3. Pain, dystonia and\u002For gut dysfunction parent-rated symptom score above threshold, defined by rating on the relevant revised Memorial Symptom Assessment Scale (MSAS) question(s) of:\n\n   1. Frequency: \"Frequently\" or \"Almost Constantly\", AND\n   2. Severity: \"Moderate\", \"Severe\", or \"Very Severe\", AND\n   3. Distress: \"Quite a bit\", or \"Very much\";\n4. No changes in medication or other interventions in the two weeks prior to randomization;\n5. Participant and family have the ability to comply with the protocol requirements, in the opinion of the investigator;\n6. Agrees not to drive for the duration of the study.\n\nExclusion Criteria:\n\n1. Non-English speaking parents.\n2. Participant history of psychosis, schizophrenia, bipolar disorder, or major depressive disorder, or a first degree family history of psychosis.\n3. Taking medications which are known to interact with medicinal cannabis: warfarin, mTOR inhibitors (e.g sirolimus, tacrolimus), anti-cancer agents, citalopram \\>20mg\u002Fday, escitalopram \\>10mg\u002Fday.\n4. Abnormal liver function tests defined as ALT \\> 3 x ULN\n5. Current use of illicit drugs or medicinal cannabis, or use in the 4 weeks prior to screening\n6. Pregnant or intending to become pregnant during the study, or breastfeeding.\n7. History of clinically significant suicidal thoughts in the prior 12 months.\n8. Life expectancy less than 3 months in the opinion of the investigators\n9. Allergy to any of the components in the investigatory products (eg sunflower oil)\n10. Diagnosis of a malignant condition","6 Months","21 Years",{"count":88,"type":23},[577,266],"PHASE1","The goal of this pilot study is to explore the feasibility and acceptability of a medicinal cannabis clinical trial into easing the symptoms of children undergoing palliative care for non-oncological conditions. The trial will evaluate the study design including recruitment strategy, medication tolerability, duration and outcomes to determine acceptability and feasibility for participating families. The data collected will then be used to design a full-scale multi-centre trial.\n\nParticipants will be randomly allocated to receive one of two medicinal cannabis products. Neither the participants nor researchers will know the study drug allocation until the end of the trial.",[580],"Palliative Care","2025-12-17",{"date":583,"type":34},"2025-12-24",{"date":585,"type":34},"2024-02-19",{"date":587,"type":23},"2026-12",{"name":40,"class":41},{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":24,"phases":599,"briefSummary":600,"conditions":601,"keywords":603,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":613,"leadSponsor":614,"locationsCount":77},"100584857","investigating-the-efficacy-of-a-paediatric-fertility-preservation-decision-aid-in-parents-and-adolescents-and-young-adults-caya-cancer-survivors-100584857","NCT06894810","Investigating the Efficacy of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivors","A Double Blind Randomised Controlled Trial of a Paediatric Fertility Preservation Decision Aid in Parents and Adolescents and Young Adults (CAYA) Cancer Survivors","FOCUS","Inclusion Criteria:\n\nInclusion Criteria for both parents and survivors:\n\n* Be able to communicate in English.\n* Signed written informed consent form.\n\nInclusion Criteria for parents only:\n\n• Parents\u002Fguardians of CAYA survivors who were ≤25 years (2) when diagnosed with cancer and have completed curative gonadotoxic treatment\n\nInclusion Criteria for survivors only\n\n* CAYA cancer survivors aged 16 years or over who have completed curative gonadotoxic treatment.\n* Participants can be on long-term adjuvant or endocrine therapy.\n* Participants may have achieved a pregnancy or livebirth.\n\nExclusion Criteria:\n\nExclusion Criteria for both parents and survivors:\n\n* CAYA patients currently undergoing cancer treatment and their parents\u002Fguardians.\n* CAYA patients who are palliative and their parents\u002Fguardians\n* A family member already in the study.\n\nExclusion Criteria for survivors only:\n\n• Minors who are not deemed to be mature minors as per protocol",{"count":598,"type":23},358,[26],"The current standard of care for paediatric patients with cancer regarding preservation of their fertility (FP) is to provide high-quality information during the clinical consultation process. However, this approach depends on health provider knowledge and communication and has been shown to be sub-optimal in some situations. This impairs the critical decision-making of patients regarding fertility testing, utilization of gametes, and continuing payment of storage fees. The fertility preservation decision aid (FP DA) may lead to a greater understanding of their fertility status for participants. This knowledge may allow participants the opportunity to assess potential fertility issues prior to the end of their reproductive window, helping to minimize missed opportunities for parenthood.\n\nThis research study aims to assess the effectiveness of the use of the FP DA on unmet fertility information needs when it is provided in addition to high-quality information in parents of cancer survivors and CAYA cancer survivors compared to high-quality information alone.",[602],"Unmet Fertility Information Needs",[604,605,606,607,608],"Fertility preservation","Child Adolescent and Young Adults","Decision Aid","CAYA","Cancer Survivors","2025-12-08",{"date":611,"type":34},"2025-12-16",{"date":609,"type":34},{"date":73,"type":23},{"name":40,"class":41},{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":621,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":18,"minAge":623,"maxAge":20,"enrollmentInfo":624,"targetDuration":4,"studyType":24,"phases":626,"briefSummary":627,"conditions":628,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":631,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":541},"100429750","phase-4-single-dose-intravenous-antibiotics-for-complicated-urinary-tract-infections-in-children-100429750","NCT04876131","Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children","CHOICE UTI - Clinical Efficacy of Single Dose (Daily) IV Antibiotics Followed by 2 Days Oral Antibiotics Compared to 3 Doses (Daily) IV Antibiotics for Children With Complicated Urinary Tract Infections: a Multicentre Randomised Trial","CHOICE UTI","Inclusion Criteria:\n\n* 3 months (corrected age) to 18 years\n* Fever (reported fever at home or measured fever of ≥38 degrees Celsius associated with the illness that triggered current ED presentation (eg fever may have been 18 hours prior to presentation but none since then because patient has been on maximal antipyretics - paracetamol or ibuprofen)\n* Any of the following complicating features: Vomiting, Rigors, History of recurrent UTI, Urological abnormalities, Tachycardia\n* Urine sample available (Urine culture must have been collected prior to or within an hour of antibiotic treatment, either at the GP or ED - in order to assess urine culture as per below).\n* Abnormal urinary dipstick leucocyte esterase \\>1+ or nitrite positive OR ≥5 White Blood Cells (WBCs) per high-power field in centrifuged urine OR≥ 10 White Blood Cells (WBCs) per mm3 in uncentrifuged urine and bacteriuria with any bacteria per high-power field\n* ED clinician determines the child requires treatment with IV antibiotics \\* In ED, only urine dipstick or urinalysis will be available. Once urine culture is available, to be included in the efficacy analysis, culture results must meet the following criteria: Positive urine culture result with no more than 2 species of microorganisms AND Spontaneously voided urine with ≥105 microorganisms per mL of urine or Suprapubic aspirate or urinary catheter with ≥104 microorganisms per mL of urine. In the absence of a positive urine culture, ultrasonographic findings supporting pyelonephritis (per reporting radiologist) will be accepted as evidence of a urinary tract infection.\n\nExclusion Criteria:\n\n* Sepsis (requiring inotropic support or more than 20ml\u002Fkg of fluid bolus in Emergency Department)\n* Known allergy to all once daily study drug options (gentamicin or ceftriaxone or amikacin)\n* If the patient has another co-existing condition which requires (based on established evidence-based guidelines) more than 1 dose of IV antibiotics eg meningitis\n* Known chronic renal failure or renal transplant patients\n* Unrepaired posterior urethral valves\n* Indwelling stent and fever\n* Previously enrolled participants in the CHOICE UTI trial.\n* No available oral antibiotic option for this UTI: urine culture result already available and multi-resistant organism with susceptibility only to IV antibiotics or known intolerance to oral antibiotics (previous UTI with multi-resistant organism not an exclusion)\n* Previous IV antibiotics for same UTI episode eg interhospital transfer whereby significant time has passed since first dose IV\n* Patients with clinically suspected renal abscess e.g., extreme renal tenderness, out of keeping with pyelonephritis (clinically determined).\n* Clinician does not intend on prescribing a course of IV antibiotics but plans on only giving a single dose from the outset\n* Recurrence of urinary tract infection within 2 weeks\n* Unable to obtain consent\n* Patient is pregnant","3 Months",{"count":625,"type":23},452,[313],"Urinary tract infections (UTI) are commonly encountered in children, with 7% diagnosed with at least one UTI by the age of 19 years. The evidence for treatment of uncomplicated UTI is clear; oral antibiotics are as good as intravenous (IV) antibiotics, usually for a total of 7 days. Complicated UTIs (cUTIs) on the other hand, are common reasons for hospital admissions for IV antibiotics and constitute a major burden for healthcare systems. There is considerable variation in care for children who present with UTI and have complicating features such as vomiting, dehydration, urological abnormalities or have a previous history of UTI. Australian and international guidelines lack clear, evidence-based recommendations to guide treatment in this group. Without gold standard evidence, these children will continue to receive unnecessary IV antibiotics, longer hospital stays and poorer health outcomes.\n\nThis multicentre, non-inferiority randomised trial will investigate if One dose - single dose of IV followed by 2 days oral antibiotics is as non-inferior to Three doses for children with UTI and co-existing complicating factors presenting to the Emergency Department (ED). In other words, this study will compare if a single dose of IV antibiotics plus two days oral antibiotics is as clinically effective as 3 doses antibiotics in resolving UTI symptoms at 72 hours after the first dose of IV antibiotics, for complicated UTIs in children presenting to the ED. All participants will receive a total of 7 days of antibiotics for the complicated urinary tract infection. If 1 dose IV and 2 days oral antibiotics is found to be as good as 3 days, the duration of IV antibiotics for complicated UTI can be reduced along with avoidance of the inherent risks of unnecessary hospital admission by administering a single IV dose in an outpatient\u002FED setting. On the other hand if a single IV dose results in prolonged symptoms or treatment failure, this will inform practice for the proportion of children who have a single dose of IV antibiotics in the ED and are sent home on oral antibiotics. Regardless of the outcome, this trial will inform clinical practice for complicated UTI to improve health outcomes for this group.",[629,346,630],"Complicated Urinary Tract Infection","Pediatric Infectious Disease",{"date":632,"type":34},"2025-12-03",{"date":634,"type":34},"2022-05-30",{"date":636,"type":23},"2028-05-16",{"name":40,"class":41},{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":18,"minAge":392,"maxAge":20,"enrollmentInfo":646,"targetDuration":418,"studyType":521,"phases":4,"briefSummary":648,"conditions":649,"keywords":653,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":660,"completionDateStruct":662,"leadSponsor":663,"locationsCount":77},"100595326","wearable-technology-and-machine-learning-for-early-detection-and-risk-assessment-of-unacceptable-toxicities-in-a-paediatric-oncology-cohort-100595326","NCT07030998","Wearable Technology and Machine Learning for Early Detection and Risk Assessment of Unacceptable Toxicities in a Paediatric Oncology Cohort","WEARABLES: Wearable Technology and Machine Learning for Early Detection and Risk Assessment of Unacceptable Toxicities in a Paediatric Oncology Cohort","WEARABLES","Inclusion Criteria:\n\n* Paediatric, adolescent or young adult diagnosis of cancer AND receiving therapy placing them at risk of infection\n* Receiving cancer treatment at The Royal Children's Hospital\n* Patients aged 5-18 years at time of the eligibility screening\n* If aged \\\u003C 16 years, parent or guardian able to provide consent\n* iPhone 8 or later (iOS must be up to date\u002Fupdated at time of enrolment)\n* At least 10MB of iPhone storage for WEARABLES app and data collection.\n* Willing and able to wear a wearable device for a period of 4 weeks (during waking hours).\n* Consent to data being shared to the WEARABLES app (owned by the research team).\n\nExclusion Criteria:\n\n* \\\u003C5 years of age.\n* \\\u003C16 years of age without guardian or parent consent.\n* Aged 16-18 and unable to provide consent.\n* Participant did not consent to wearing Apple Watch for a period of 4 weeks.",{"count":647,"type":23},150,"Data collection study to establish a predictive model of infection observed during childhood cancer therapy using data captured by wearable technology.",[650,346,651,652],"Cancer","Digital Health","Wearable Devices",[650,654,346,655,656],"Paediatric","Treatment Toxicity","Wearable Device","2025-11-14",{"date":659,"type":34},"2025-11-17",{"date":661,"type":34},"2025-10-15",{"date":539,"type":23},{"name":40,"class":41},{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":668,"acronym":669,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":18,"minAge":86,"maxAge":20,"enrollmentInfo":671,"targetDuration":4,"studyType":24,"phases":673,"briefSummary":674,"conditions":675,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":680,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":684,"locationsCount":88},"100403801","phase-4-bone-and-joint-infections---simplifying-treatment-in-children-trial-100403801","NCT04538053","BonE and Joint Infections - Simplifying Treatment in Children Trial","BEST","Inclusion Criteria:\n\n* Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria.\n\nExclusion Criteria:\n\n1. Infection due to bacteria resistant to cefalexin or atypical infection (e.g. mycobacterial, fungal)\n2. Features of sepsis as defined by the presence of organ dysfunction (defined using definitions within the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score)\n3. Concomitant severe, invasive infection e.g. necrosing fasciitis\n4. Complicated infection (e.g. presence of prosthetic material; large subperiosteal (\\>3mm) or soft tissue abscess without surgical intervention; infection secondary to or complicated by trauma)\n5. History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins\n6. Received more than three IV or oral dose of an antibiotic with activity against the likely bacteria causing the current infection\n7. Prior episode of OM or SA\n8. Prior condition predisposing to poor absorption (e.g. inflammatory bowel disease, current gastrointestinal symptoms) or complicated disease (e.g. immunodeficiency)\n9. Prior enrolment in the trial\n10. Current recipient of another investigational product as part of a clinical trial",{"count":672,"type":23},285,[313],"This is a multi- centre trial of children with bone and joint infections (BJIs) at eight major paediatric hospitals in Australia and New Zealand. The primary objective is to establish if in children with acute, uncomplicated BJIs, entirely oral antibiotic treatment is not inferior to initial intravenous (IV) treatment for 1 to 7 days followed by an oral antibiotic course in achieving full recovery 3 months after presentation. Children will be randomly allocated to the 'entirely oral antibiotic' group or the 'standard treatment' group.",[676,677,678,679],"Bone Infection","Septic Arthritis","Bone and Joint Infection","Osteomyelitis",{"date":659,"type":34},{"date":682,"type":34},"2021-06-01",{"date":587,"type":23},{"name":40,"class":41},{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":691,"eligibilityCriteria":692,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":139,"enrollmentInfo":693,"targetDuration":4,"studyType":24,"phases":695,"briefSummary":696,"conditions":697,"keywords":702,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":703,"lastUpdatePostDateStruct":704,"startDateStruct":706,"completionDateStruct":708,"leadSponsor":709,"locationsCount":77},"100600150","perspectives-on-antibiotics-and-tracking-symptoms-in-children-100600150","NCT07093749","Perspectives on Antibiotics and Tracking Symptoms in Children","PATSy Perspectives on Antibiotics and Tracking Symptoms in Children - a Mixed Methods Feasibility Study","PATSy","Inclusion Criteria:\n\n* Between the ages of ≥ 4 years and ≤ 17 years at enrolment.\n* Diagnosed with any of the following at RCH ED: urinary tract infection (UTI), cellulitis, impetigo, pharyngitis, tonsillitis, respiratory tract infections, otitis media.\n* Prescribed oral antibiotics (either immediately or as switch from IV antibiotics after transfer to HITH) as standard of care due to having uncomplicated infection as deemed by their treating doctor.\n* Parent\u002Fguardian provides a signed and dated informed consent form.\n\nExclusion Criteria:\n\n\\- Parent\u002Fguardian does not speak English",{"count":694,"type":23},300,[26],"The study will assess families' perspectives and decision-making regarding the duration of oral antibiotic courses prescribed to children (4-17 years) who present with uncomplicated bacterial infections at the Royal Children's Hospital (RCH) Emergency Department (ED). The study will involve (i) children discharged from ED on oral antibiotics and (ii) children transferred to Hospital-in-the-Home (HITH) on IV antibiotics who then switch to oral antibiotics. In addition, the study will assess how feasible and acceptable it is to track children's symptoms via the Garmin Smartwatch and the WeGuide platform (WeGuide is a patient engagement software platform that allows for enrolment, consent, and data collection \\[via questionnaires\u002Fsurveys and from the Garmin Smartwatches\\] through a singular platform).",[341,342,698,699,700,343,701],"Impetigo","Pharyngitis","Tonsillitis","Otitis Media",[62,347,651,346],"2025-09-17",{"date":705,"type":34},"2025-09-22",{"date":707,"type":34},"2025-09-16",{"date":100,"type":23},{"name":40,"class":41},""]