[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infant":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,48,77,108,136,170,198,229,255,285],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100639553","automated-oxygen-control-in-preterms-on-non-invasive-ventilation-100639553",false,"NCT07622563","Automated Oxygen Control in Preterms on Non-invasive Ventilation","Randomised Controlled Trial of Closed-loop Automated Oxygen Control in Preterm Infants Receiving Non-invasive Respiratory Support","Inclusion Criteria:\n\nPreterm infants \\\u003C34 weeks of gestation and at any postnatal age on non-invasive respiratory support including:\n\n* non-invasive positive pressure ventilation (NIPPV)\n* nasal CPAP\n* HHFNC oxygen, either as primary or post extubation respiratory support.\n\nExclusion Criteria:\n\n* Infants with congenital cyanotic heart disease.\n* Infants with other know major congenital abnormalities.","ALL","22 Weeks","34 Weeks",{"count":20,"type":21},76,"ESTIMATED","INTERVENTIONAL",[24],"NA","This randomised controlled trial aims to investigate the effectiveness of closed-loop automated oxygen control (CLAC) in preterm infants receiving non-invasive respiratory support and determine if it reduces the duration of supplementary oxygen treatment and improves achievement of oxygen saturation targets, reduces the incidences of hypoxia and hyperoxia, the number of manual adjustments to the inspired oxygen concentration (FiO2), and adverse outcomes including bronchopulmonary dysplasia (BPD).\n\nThe study will take place at King's College Hospital neonatal intensive care unit (NICU). Parents of preterm infants born at less than 34 weeks of gestation and receiving non-invasive respiratory support will be approached, informed and if appropriate consented to join the trial.\n\nParticipants will be randomised to receiving either automated or manual oxygen control.\n\nThe study will measure outcomes including the duration of supplementary oxygen treatment, the percentage of time spent within oxygen saturation targets, the incidences of hypoxia and hyperoxia, the number of manual FiO2 adjustments required, the overall duration of non-invasive respiratory support and length of neonatal unit stay, and the incidence of BPD at 36 weeks postmenstrual age (PMA). Results will be compared between the two groups.",[27,28,29],"Infant","Premature","Airway Morbidity",[31,32,33,34],"automated oxygen control","non-invasive respiratory support","randomised controled trial","neonates","NOT_YET_RECRUITING","2026-05-27",{"date":38,"type":39},"2026-06-03","ACTUAL",{"date":41,"type":21},"2026-06-01",{"date":43,"type":21},"2027-09",{"name":45,"class":46},"King's College Hospital NHS Trust","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":47},"100444837","high-medium-chain-triglyceride-nutritional-support-in-infants-with-biliary-atresia-100444837","NCT05072626","High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia","Study on High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia After Kasai Portoenterostomy","Inclusion Criteria:\n\nThe Kasai procedure for infants with biliary atresia under the age of 3 months.\n\nExclusion Criteria:\n\n* Complicated with cirrhosis, hepatitis, or other hepatic disorders;\n* Complicated with other systemic serious diseases (such as congenital multiple malformations, chromosome abnormalities)","3 Months",{"count":57,"type":21},300,"OBSERVATIONAL","This study is a prospective, single center and observational open clinical study.",[61,27,62,63],"Biliary Atresia","Nutrition Support","Medium-chain Triglyceride",[61,65,62,66],"Kasai portoenterostomy","medium-chain triglyceride","RECRUITING","2026-03-30",{"date":70,"type":39},"2026-04-03",{"date":72,"type":39},"2021-10-11",{"date":74,"type":21},"2028-12-31",{"name":76,"class":46},"Children's Hospital of Fudan University",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":47},"100629043","coaching-learning-empowerment-in-cerebral-palsy---a-6-week-integrated-ptot-caregiver-primer-bootcamp-for-infants-diagnosed-with-or-at-high-risk-for-cerebral-palsy-100629043","NCT07469514","Coaching, Learning, Empowerment in Cerebral Palsy - a 6-Week Integrated PT\u002FOT Caregiver \"Primer\" Bootcamp for Infants Diagnosed With or at High Risk for Cerebral Palsy","CIRCLE-CP Study: Coaching, Learning, Empowerment in Cerebral Palsy - a 6-Week Integrated PT\u002FOT Caregiver \"Primer\" Bootcamp for Infants Diagnosed With or at High Risk for Cerebral Palsy","CIRCLE-CP","Inclusion Criteria:\n\n* Infants 3-15 months corrected age at enrollment\n* Diagnosed with CP or at high possibility of CP\n* Not yet independently walking at baseline\n* Medically stable for therapeutic handling and group play\n* Primary caregiver (\\>=18years) able to attend all weekly group sessions\n* English-speaking only\n\nExclusion Criteria:\n\n* Unstable medical condition (eg, frequent desaturations, emeses, uncontrolled seizures) or acute restrictions incompatible with participation\n* Concurrent enrollment in another intensive motor program\n* Profound sensory impairments that preclude group program participation","15 Months",{"count":87,"type":21},32,[24],"This study focuses on the caregiver's knowledge, comfort, and confidence in interacting with and supporting their infant with Cerebral Palsy (CP) or at high risk for Cerebral Palsy. Four caregivers with their infants will be in one cohort to assess the benefits of group intervention. The intervention is delivered in a group, bootcamp-style educational format led by clinical team including pediatric physiatrist, physical therapist and occupational therapist.",[91,92,93,27],"Cerebral Palsy","Cerebral Palsy (CP)","Cerebral Palsy Infantile",[95,96,97,98],"physical therapy","occupational therapy","caregivers","caregiver","2026-03-10",{"date":101,"type":39},"2026-03-13",{"date":103,"type":21},"2026-04",{"date":105,"type":21},"2027-04",{"name":107,"class":46},"University of California, San Francisco",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100503702","optimizing-tracheal-intubation-outcomes-and-neonatal-safety-100503702","NCT05838690","Optimizing Tracheal Intubation Outcomes and Neonatal Safety","OPTION SAFE","Inclusion Criteria:\n\nInfants undergoing tracheal intubation in the neonatal intensive care unit (NICU)\n\nExclusion Criteria:\n\nEndotracheal tube exchanges, as this represents a distinct procedure.","1 Year",{"count":117,"type":21},3000,[24],"The purpose of the study is to assess the impact of a personalized intubation planning tool, the Personalized INtubation Safety (PINS) Bundle on intubation procedural safety and clinical outcomes among patients intubated in the neonatal intensive care unit (NICU) setting.",[27,121],"Intubation Complication",[27,123,124,125],"Intubation","NICU","Safety","2026-03-03",{"date":128,"type":39},"2026-03-04",{"date":130,"type":39},"2023-04-01",{"date":132,"type":21},"2027-12-31",{"name":134,"class":46},"Children's Hospital of Philadelphia",8,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":144,"sex":16,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":155,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":169},"100608865","effect-of-follow-on-formula-on-the-gut-microbiota-of-healthy-infants-100608865","NCT07207109","Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.","A Double-blind Randomised Controlled Study to Investigate the Effect of a follow-on Formula With a Specific Synbiotic Mixture on the Gut Microbiota Composition in Healthy Infants.","FUNTASTIC","Inclusion Criteria:\n\n1. Healthy infants as per the clinical judgement of the Investigator\n2. Singleton infants\n3. Infants ≥6 months and ≤9 months of age at Visit 1\n4. Infant's weight-for-age WHO z-score within ± 2 SD at Visit 1\n5. Infants fed with an infant or follow-on formula at Visit 1.\n6. Infants are familiar with, and are expected to drink, ≥600 mL formula per day.\n7. Written informed consent (IC) from parent(s) and\u002For legally acceptable representative(s) aged ≥18 years at Visit 1.\n\nExclusion Criteria:\n\n1. Infants with known or suspected medical conditions requiring a special diet or special formulae, food allergy, or food intolerances\n2. Infants who received breastfeeding ≤14 days before Visit 1\n3. Infants who are potty-trained\n4. Infants with current or previous illnesses\u002Fconditions and\u002For known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.\n5. Use of medication or nutritional products\u002Ffood supplements known to impact the study outcomes ≤14 days before Visit 1 or expected need during the study.\n6. Infants with previous, current, or intended participation in any other clinical study involving investigational or marketed products.\n7. Incapability of infants' parents and\u002For legally acceptable representative(s) to comply with study protocol as per the judgement of the investigator or investigator's uncertainty about the willingness or ability of parents legally acceptable representative(s) to comply with the protocol requirements, including access to a phone.\n8. Children of employees and\u002For family members or relatives of employees of Danone, the participating sites, or any other nutrition company that develops infant, follow-on or young child formulae.",true,"6 Months","9 Months",{"count":148,"type":21},268,[24],"This study investigates the effects of follow-on formula in infants aged 6-9 months over a 12-week period. After parents give consent, their baby's feeding habits, stool characteristics, and any illnesses or medication use will be recorded. Infants will be randomly assigned to receive either the test or control product. Growth and health data will be collected during study visits.\n\nParents will collect stool samples and complete diaries to help researchers better understand the baby's digestion and overall health. A follow-up phone call will be made to check on the baby's well-being after the study ends.",[152,27,153,154],"Follow-on Formula","Faeces","Gut Microbiota",[156,157,158],"Follow-on formula","healthy infants","gut microbiota","2025-10-02",{"date":161,"type":39},"2025-10-03",{"date":163,"type":21},"2025-11",{"date":165,"type":21},"2027-06",{"name":167,"class":168},"Nutricia Research","INDUSTRY",2,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":178,"maxAge":115,"enrollmentInfo":179,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":47},"100585965","relevance-of-veinous-lactates-to-predict-postoperative-complications-in-children-0-1-years-100585965","NCT06909227","Relevance of Veinous Lactates to Predict Postoperative Complications in Children 0-1 Years","Relevance of Veinous Lactates Dosage at the End of a Surgical Procedure to Predict Postoperative Complications in Children 0-1 Years","PLANN","Inclusion Criteria:\n\n* surgery under general anesthesia\n* age \\\u003C 1 year\n\nExclusion Criteria:\n\n* ambulatory surgery\n* cardiac surgery\n* preoperative hemodynamic instability\n* Weight \\\u003C 2 kg","0 Years",{"count":180,"type":21},500,"This study will investigate if the dosage of veinous lactate at the end of a surgical procedure is related to post-operative complications occurring within 3 months in young infants aged 0-1 years.\n\nBlood samples are acquired routinely before emergence of general anesthesia, from the IV line put in place for anesthesia.\n\nThe investigators hypothesized that elevated lactates would be associated with more postoperative complications in this population, as is the case in adults.",[183,27],"General Anesthesia",[185,186,187,188],"pediatric","anesthesia","lactate","complications","2025-04-29",{"date":191,"type":39},"2025-05-01",{"date":193,"type":39},"2025-03-27",{"date":195,"type":21},"2026-09-30",{"name":197,"class":46},"Hôpital Armand Trousseau",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":204,"maxAge":145,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":214,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":47},"100589677","comparison-of-the-effectiveness-of-face-to-face-rehabilitation-and-telerehabilitation-in-infants-with-congenital-muscular-torticollis-100589677","NCT06957522","Comparison of the Effectiveness of Face to Face Rehabilitation and Telerehabilitation in Infants With Congenital Muscular Torticollis","Inclusion Criteria:\n\n* Infants aged 0 to 6 months\n* Diagnosed with congenital muscular torticollis (CMT)\n* Classified as Grade 1 to 3 CMT severity based on clinical assessment\n\nExclusion Criteria:\n\n* Plagiocephaly\n* Ocular torticollis\n* Neurological complications\n* Musculoskeletal disorders of the cervical spine\n* Visual impairments\n* Hearing impairments","0 Months",{"count":206,"type":21},42,[24],"Who is this study for? This study is designed for infants aged 0-6 months who have been diagnosed with Congenital Muscular Torticollis (CMT). CMT is a condition observed at birth or shortly after, characterized by the shortening of the sternocleidomastoid (SCM) muscle, leading to the baby's head tilting to one side and rotating to the opposite side. It affects both boys and girls and may result in limited neck movement, abnormal posture, facial asymmetry, and potential developmental delays if left untreated.\n\nWhat is the purpose of this study? The goal of this study is to compare the effectiveness of two different physical therapy methods-face-to-face rehabilitation and telerehabilitation-in treating infants with CMT. In addition to evaluating the outcomes of these two therapy methods, this research also aims to provide families with reliable, accessible information through a web-based educational platform.\n\nWhy is this study important? Early diagnosis and intervention are crucial for optimal recovery in infants with CMT. Studies show that infants who begin therapy by one month of age have up to a 98% chance of full recovery. However, if diagnosis and treatment are delayed, the recovery process can take longer and may be less effective. This study will help determine if online (telerehabilitation) sessions can be just as effective as traditional face-to-face therapy, offering a flexible and accessible treatment option for families.\n\nWhat are the benefits of participating?\n\n* Access to a structured, evidence-based rehabilitation program for your child\n* Guidance from trained pediatric physiotherapists\n* Increased awareness and knowledge about CMT through a web-based family education platform\n* Contribution to research that may benefit other children and families in the future\n* Evaluation of your baby's progress through professional assessments\n\nWhat will the therapy program involve?\n\nParticipants will be randomly assigned to either a face-to-face or telerehabilitation group. Both groups will follow the same therapy program, focusing on:\n\n* Increasing passive and active neck movements\n* Promoting symmetrical head and body movement\n* Providing recommendations for environmental adjustments\n* Educating parents or caregivers on home-based exercises and care\n\nProgram structure:\n\n* Face-to-face group: Therapy sessions will be conducted in a clinic setting, twice a week for 30 minutes each session, over a period of 8 weeks.\n* Telerehabilitation group: Therapy sessions will be conducted via Zoom, with the same frequency, duration, and content as the face-to-face sessions.\n\nHow will outcomes be measured?\n\nInfants will be assessed before and after the 8-week therapy period for:\n\n* Passive cervical range of motion (rotation and lateral flexion)\n* Gross motor function\n* Muscle function Parental adherence to the home program will also be evaluated through a questionnaire. A follow-up will be conducted one month after therapy ends.\n\nHow can I participate? If your infant is aged 0-6 months and has been diagnosed with CMT, you may be eligible to participate. You will need access to a device with internet for telerehabilitation sessions, if assigned to that group. Participation is voluntary and free of charge. Families will receive detailed instructions and ongoing support throughout the program.\n\nAdditional Resources:\n\nAs part of this study, a web-based educational platform will be made available to all participating families. This platform will include:\n\n* Clear explanations about CMT\n* Instructional videos and home exercise guides\n* Tips for daily care and positioning\n* Frequently asked questions (FAQ) for parents Why is this research unique? This is one of the first studies to scientifically compare face-to-face and online rehabilitation for CMT infants, while also providing a reliable online resource for families. It aims to help develop alternative, flexible care models that meet the diverse needs of families and infants.\n\nContact Information:\n\nIf you are interested in participating or would like more information, please contact our research team at:\n\n\\[fgokcenalaca@gmail.com \u002F +905534646606\\] We are committed to supporting your child's health and development. Thank you for considering being a part of this important study.",[27,210,211,212,213],"Torticollis Congenital","Neurodevelopment Treatment","Telerehabilitation","Physiotherapy and Rehabilitation",[215,216,217,218,219],"telerehabilitation","congenital torticollis","infant","neurodevelopment treatment","physiotherapy and rehabilitation","2025-04-25",{"date":222,"type":39},"2025-05-04",{"date":224,"type":21},"2025-05-25",{"date":226,"type":21},"2026-12-25",{"name":228,"class":46},"Istanbul University - Cerrahpasa",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":16,"minAge":236,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":47},"100511072","latin-american-surgical-outcomes-study-in-pediatric-patients-100511072","NCT05934682","Latin American Surgical Outcomes Study in Pediatric Patients","LASOS-Peds","Inclusion Criteria:\n\n* All of the consecutive patients under 18-years-old who were admitted to participating hospitals during the study period and who underwent elective and nonelective surgeries will be included in the study.\n\nExclusion Criteria:\n\n1. patients undergoing radiological or other procedures that do not require general anesthesia or in which general anesthesia is performed but no procedure is performed (e.g., general anesthesia during MRI);\n2. patients undergoing obstetric surgery.","1 Day","18 Years",{"count":239,"type":21},10000,"This prospective, international, multicenter observational study will include hospitals performing pediatric surgery in participating Latin American countries.\n\nWe aim to assess the incidence of hospital postoperative complications in pediatric surgical patients \\\u003C 18-years-old in Latin America. We will recruit all consecutive pediatric patients under the age of 18 years who were admitted to participating hospitals undergoing elective and nonelective surgery. The primary outcome is in-hospital postoperative complications up to 30 days after surgery.",[242,243,244,27,245],"Postoperative Complications","Children","Neonate","Anesthesia","2024-12-05",{"date":248,"type":39},"2024-12-09",{"date":250,"type":39},"2023-12-20",{"date":252,"type":21},"2025-03-30",{"name":254,"class":46},"University of Sao Paulo",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":270,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":47},"100439452","infants-with-severe-acute-respiratory-distress-syndrome-the-prone-trial-100439452","NCT05002478","Infants with Severe Acute Respiratory Distress Syndrome: the Prone Trial","Short-Term Effect of Prone Positioning in Infants with Severe Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\n* Patients hospitalized at Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU) of the Medical University Vienna.\n* Patients aged \\>36 weeks (corrected gestational age) and \\\u003C24 months.\n* Patient intubated and mechanically ventilated for at least 6 hours, with an expected requirement of invasive ventilatory support for at least 12 hours.\n* Clinical picture strongly suggestive for acute bronchiolitis or pneumonia (fever, fine crackles, prolonged expiration, lung hyperinflation and\u002For findings of new infiltrates consistent with acute pulmonary parenchymal disease on chest X-ray).\n* Severe pediatric acute respiratory distress syndrome (ARDS), defined by OSI ≥12.3 (wean FIO2 to maintain SpO2 ≤ 97% to calculate oxygen saturation index).\n* Written informed consent obtained from parents.\n\nExclusion Criteria:\n\n* Clinical context\n\n  * Need for O2 supplementation to maintain SpO2\\>94% in the 4 weeks preceding hospitalization in the PICU\u002FNICU\n  * Cyanotic congenital heart disease Cardiogenic pulmonary edema\n  * Severe pulmonary hypertension\n  * Untreated pneumothorax\n  * Severe neurological abnormalities\n  * Other severe congenital anomalies such as congenital diaphragmatic hernia\n  * Ongoing cardiopulmonary resuscitation or limitation of life support\n* Contradictions for prone positioning (adapted from Guerin, C., et al., Prone positioning in severe acute respiratory distress syndrome. N Engl J Med, 2013. 368(23): p. 2159-68):\n\n  * Intracranial pressure \\>30 millimeters of mercury (mmHg) in supine position or cerebral perfusion pressure \\\u003C60 mmHg\n  * Massive hemoptysis requiring an immediate surgical or interventional radiology procedure\n  * Tracheal surgery or sternotomy during the previous 15 days\n  * Serious facial trauma or facial surgery during the previous 15 days\n  * Deep venous thrombosis treated for less than 2 days\n  * Cardiac pacemaker inserted in the last 2 days\n  * Unstable spine, femur, or pelvic fractures\n  * Use of extracorporeal membrane oxygenation (ECMO) before inclusion\n  * Lung transplantation\n  * Burns on more than 20% of the body surface\n* Other non-inclusion criteria\n\n  * Indication not to attempt resuscitation\n  * Patient already recruited for other clinical studies\n  * Patients who already received surfactant in the last 4 weeks\n  * Thoracic skin lesions or wounds on the thorax, where the EIT-electrode-belt would be placed","12 Months",{"count":264,"type":21},14,[24],"The main objective is to determine the short-term effect of prone positioning in infants with infection-associated severe acute respiratory distress syndrome. The investigators compare oxygenation parameters and measurements from electrical impedance tomography (EIT) and lung ultrasonography (LUS) in mechanically ventilated infants in prone position versus supine position after surfactant administration.",[268,269,27],"Acute Lung Injury\u002FAcute Respiratory Distress Syndrome (ARDS)","Surfactant Dysfunction",[271,272,273,274,275],"Acute Respiratory Distress Syndrome","Electrical Impedance Tomography","Lung Ultrasonography","Prone Position","Infants","2024-11-18",{"date":278,"type":39},"2024-11-20",{"date":280,"type":39},"2022-07-30",{"date":282,"type":21},"2026-12-31",{"name":284,"class":46},"Medical University of Vienna",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":22,"phases":294,"briefSummary":295,"conditions":296,"keywords":301,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":47},"100457394","family-centred-healthcare---zero-separation-and-couplet-care-100457394","NCT05236023","Family Centred Healthcare - Zero Separation and Couplet Care","Evaluation of a Family-centred Care Intervention Based on Zero Separation and Couplet Care","Inclusion Criteria:\n\n* Mothers with a treatment-requiring condition such as preeclampsia, bleeding, psychological diagnoses, discontinued milk production and infection.\n* Infant from gestational age 28 weeks with a treatment-requiring condition such as respiratory distress syndrome (with respiratory support including mechanical ventilation), hyperbilirubinemia, infection, and low blood sugar.\n\nExclusion Criteria:\n\n* Healthy mothers who does not need care and treatment, and has an infant admitted at NICU.\n* Mothers who are admitted at an adult intensive care unit due to severe sickness (severe preeclampsia with spasm, severe bleeding of 4-5 liter, and severe HELLP syndrome) - counting one-two mothers a year",{"count":293,"type":21},556,[24],"Today mother and infant are routinely separated directly after birth if there is a need of specialised treatment and care, despite of the significant and positive effects of skin-to-skin contact. Thus, there is a need of change in organizing the treatment and care in a way that minimizes separation.\n\nThe aim is to evaluate the implementation and effect of a complex family-centred intervention based 107 on zero separation and couplet care.\n\nThe intervention is rooted in the philosophy of family-centred care. Essentially, mother infant dyads will be admitted together, where they will receive couplet care by neonatal nurses. The study comprises a quasi-experimental trial and a qualitative process evaluation including a field study and two interview studies. Finally, a health economic evaluation will be conducted to assess the cost-effectiveness of this complex intervention. The intervention will take place at the Neonatal Intensive Care Unit at Hvidovre Hospital. The nurses will as a part of the intervention be educated to take care of both mother and infant and carry out the intervention.\n\nFive families with experiences from the Neonatal Intensive Care Unit and the Maternity Unit participates as patient and public representative in the project, as their experiences and ideas will provide an added value to the project.\n\nThis study contribute with a new perspective on how to organize the treatment and care of a newborn family in a Neonatal Intensive Care Unit. The study will be the first to examine zero separation and couplet care within sick mother-infant dyads. The study will provide knowledge about how an intervention consisting of zero separation and couplet care can be feasible and acceptable, and what kind of effect and impact it will provide. It is expected that the study as a whole may impact and profile clinical nursing, as well as benefitting public health.",[297,298,27,299,300],"Premature Birth","Post Partum","Mother-Child Relations","Family",[302,303,304],"preterm infants","zero-separation","Family centred care","2024-08-20",{"date":307,"type":39},"2024-08-21",{"date":309,"type":39},"2022-06-14",{"date":311,"type":21},"2026-08-31",{"name":313,"class":46},"Copenhagen University Hospital, Hvidovre"]