[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intensive-care-pediatric\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intensive-care-pediatric":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,78,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100567142","experiences-reported-by-siblings-of-children-hospitalized-in-the-picu-100567142",false,"NCT06664333","Experiences Reported by Siblings of Children Hospitalized in the PICU","SIBCARE","Inclusion Criteria:\n\n* Children and adolescents aged 9 to 18 years\n* Whose sister or brother is hospitalized in pediatric intensive care at Necker-Enfants Malades hospital or Robert Debré hospital\n* Holders of parental authority and children or adolescents informed and consenting to participate in the study\n\nExclusion Criteria:\n\n* Death of patients\n* Language barrier (French not mastered)\n* Inability to participate in a semi-structured interview (intellectual disability)","ALL","9 Years","18 Years",{"count":20,"type":21},20,"ESTIMATED","OBSERVATIONAL","The care for a child in pediatric intensive care is recognized as a traumatic experience for the patient and their entourage. The needs and feelings of parents are relatively well supported in the literature. However, there is still too little data concerning siblings, who can nevertheless be impacted by this difficult life experience. The study consists of conducting two semi-structured interviews with siblings of children hospitalized in pediatric intensive care at Necker-Enfants Malades Hospital and Robert Debré Hospital. The first interview will take place during the stay in intensive care, the second one 1 month after discharge from pediatric intensive care.",[25],"Intensive Care Pediatric",[27,28,29,30,31],"Pediatric intensive care hospitalisation","Siblings","Semi-structured interviews","Post-traumatic stress disorder","Major depressive syndrome","RECRUITING","2025-11-24",{"date":35,"type":36},"2025-12-01","ACTUAL",{"date":38,"type":36},"2025-01-21",{"date":40,"type":21},"2027-12-21",{"name":42,"class":43},"Assistance Publique - Hôpitaux de Paris","OTHER",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":44},"100561543","the-effect-of-music-therapy-on-vital-signs-and-heart-rate-variability-of-pediatric-patients-during-the-extubation-process-100561543","NCT06591533","The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process.","The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process in the Pediatric Intensive Care Unit","Inclusion Criteria:\n\n* Pediatric patients hospitalized who are undergoing an extubation process.\n\nExclusion Criteria:\n\n* Pediatric patients with accidental extubation will be excluded.","1 Month","17 Years",{"count":55,"type":21},82,"INTERVENTIONAL",[58],"NA","The extubation process is critical to the future health outcomes of the pediatric patient because it tests the ability of the respiratory system to function without the support of mechanical ventilation. However, extubation can cause stress, pain, anxiety, or discomfort in the patients, which results in an increased likelihood of reintubation. Music therapy has been shown to be effective in reducing anxiety and stress levels in ventilated adult patients, but studies evaluating the effect of music therapy on vital signs in pediatric patients during extubation are lacking.\n\nThe aim is to determine the effect of music therapy on vital signs and heart rate variability of pediatric patients during extubation in in two high-complexity health care institutions in Colombia.\n\nThis study is a Randomized clinical trial (RCT) with two parallel arms. The intervention group (IG) will receive standard care during the extubation process + music therapy and the control group (CG) will receive standard care only. The primary outcome measure is heart rate (HR) measured every minute for 5 minutes before extubation, during extubation, and up to 10 minutes after extubation. Secondary measures are: oxygen saturation, respiratory rate, blood pressure, duration of the procedure, number of reintubations, and heart rate variability.",[61,25],"Respiratory Failure",[63,64,65,66,67,68],"vital signs","Pediatric Intensive Care Unit","extubation","music therapy","mechanical ventilation","hear rate","2025-09-19",{"date":71,"type":36},"2025-09-24",{"date":73,"type":36},"2025-09-01",{"date":75,"type":21},"2026-12-31",{"name":77,"class":43},"Claudia Aristizábal",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":56,"phases":90,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100571581","phase-3-corticosteroids-before-extubation-in-pediatric-intensive-care-unit-100571581","NCT06722118","Corticosteroids Before Extubation in Pediatric Intensive Care Unit","Corticoïdes Avant Extubation en réanimation pédiatrique : étude Multicentrique, Prospective, randomisée, Contre Placebo","COBEX-PED","Inclusion Criteria:\n\n* Patients intubated with an endotracheal tube with or without a cuff,\n* Aged from 2 days post-term to 6 years,\n* On mechanical ventilation for at least 36 hours,\n\nAnd meeting the following extubation criteria:\n\n* Extubation planned by the medical team\n* Fraction of inspired oxygen (FiO2) ≤ 45%,\n* Oxygen saturation measured by pulse oximeter ≥ 95% or appropriate according to the pathology,\n* Positive end-expiratory pressure (PEEP) ≤ 8 cmH2O,\n* Peak inspiratory pressure ≤ 22 cmH2O or presence of cough.\n* Affiliated with a social security system,\n* Collection of informed consent from the parental authority, by both parents or the legal guardian(s).\n\nExclusion Criteria:\n\n* Refusal of consent by at least one parent or by the legal guardian(s),\n* Patient with a contraindication to IV-DXM:\n\n  * Uncontrolled local or general infection,\n  * Active viral infections (hepatitis, herpes, chickenpox, shingles),\n  * Live vaccines,\n  * Severe coagulation disorders,\n  * Ongoing gastrointestinal bleeding,\n  * Known hypersensitivity to IV-DXM or one of its excipients.\n* Patient participating in another interventional study involving human subjects or being in the exclusion period following a previous study involving human subjects, if applicable,\n* Patient receiving State Medical Aid,\n* Patient on long-term NIV,\n* Known upper airway pathology (UAP) before intubation or at the time of extubation,\n* History of UAP surgery within the month preceding inclusion,\n* Any situation deemed incompatible with the child's participation in the trial at the discretion of the investigating physician,\n* Decision to limit or stop therapeutic interventions.\n* Premature patients aged less than 40 weeks of gestation\n* Newborns aged less than 2 days after post-term birth","2 Days","6 Years",{"count":89,"type":21},348,[91],"PHASE3","Fifty to 60% of children admitted to a pediatric intensive care unit (PICU) are placed under invasive mechanical ventilation (MV) at least once during their stay. After extubation, about 30% of these patients will experience respiratory distress due to upper airway obstruction (RDUAO), and about one-third of these cases will require re-intubation. Treating this RDUAO extends the length of stay in the PICU.\n\nPre-extubation corticosteroid therapy has been validated in adults as a preventive treatment for the occurrence of RDUAO. However, the lack of robust data in pediatrics has not allowed for a consensus on the benefit of its use in children on MV in the PICU.\n\nThe investigators propose to conduct a randomized, multicenter, double-blind, placebo-controlled study evaluating the effect of intravenous dexamethasone (IV-DXM) before extubation on the incidence of RDUAO in children.",[25],[95,96],"Corticosteroids","Intensive Care Pediatrics","NOT_YET_RECRUITING","2025-04-25",{"date":100,"type":36},"2025-04-27",{"date":102,"type":21},"2025-06-15",{"date":104,"type":21},"2028-07",{"name":42,"class":43},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100572549","oxy-picu-neurodevelopmental-follow-up-study-100572549","NCT06734715","Oxy-PICU Neurodevelopmental Follow-up Study","Oxy-PICU ND","Inclusion Criteria:\n\n1. Parent or caregiver of child included in the Oxy-PICU RCT;\n2. Provided consent to be contacted about future research;\n3. Living with child; and\n4. Child\u002Fyoung person survival status confirmed.\n\nExclusion Criteria:\n\nNone.",{"count":114,"type":21},556,"Background to the research: Each year around 20,000 children are admitted to paediatric intensive care units (PICUs) in the UK. Of these children, \\~75% will receive support from a breathing machine (or ventilator) in combination with additional oxygen. We recently completed the NIHR funded Oxy-PICU randomised clinical trial (RCT) - a study that compares one treatment against another to determine which is best. The Oxy-PICU RCT investigated whether children in PICU who are receiving help from a ventilator with additional oxygen, should have their oxygen levels kept at a lower level or higher level which currently used in the NHS. We found that aiming for lower oxygen levels was better and resulted in a small but significant reduction in the number of days children spent on machines or died at 30 days.\n\nWhile small, this result would have a large and important impact for patients and their families and may have important cost savings for the NHS. However, while in the short-term targeting lower oxygen levels appears better, the effects on children's longer-term development are unknown. Knowing this is important to fully inform doctors and nurses about the effects of aiming for lower oxygen levels, and help the results of Oxy-PICU be applied throughout the NHS.\n\nAim of the research: This research aims to complete longer-term follow-up of children included in the Oxy-PICU RCT. We will look at the effect of aiming for lower oxygen levels compared to higher oxygen levels on longer-term developmental milestones.\n\nResearch plan: We will invite 1,112 parents of children included in the Oxy-PICU RCT by email and post to take part. We will arrange a telephone interview with the parent(s) who agree to participate. A trained researcher will use standard questionnaires to measure important issues. They'll establish if the children are meeting their developmental milestones and learn about their health related quality of life. After the interview we will provide a report to the parents detailing their child's development. We anticipate 50% of those approached will agree to take part in this study. This will allow us to detect important differences in developmental milestones in children treated with lower oxygen levels.\n\nPatient and public involvement: PPI has been essential throughout Oxy-PICU. Our PPI co-applicant has been involved in Oxy-PICU from the start as a key member of the study team and will continue to help oversee all aspects of this research. We will also appoint a parent advisory group to provide additional PPI input into the study processes.\n\nKnowledge mobilisation: Outputs from the neurodevelopmental follow-up will be specifically targeted to the key stakeholders including patients\u002Fparents, clinicians and policy makers. Outputs for patients\u002Fparents and the public will be co-produced with our PPI representatives.",[25],[118,119,120],"Neurodevelopment","Paediatric critical care","Oxygen","2024-12-11",{"date":123,"type":36},"2024-12-16",{"date":125,"type":21},"2025-01",{"date":127,"type":21},"2026-09",{"name":129,"class":43},"Intensive Care National Audit & Research Centre"]