[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prematurity-extreme\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prematurity-extreme":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,58,93,129,151],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":24,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":38,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100581994","assessing-intellectual-and-motor-outcomes-in-high-risk-infants-100581994",false,"NCT06857539","Assessing Intellectual and Motor Outcomes in High-risk Infants","The ELEVATE Program for Prediction, Early Detection & Intervention in Cerebral Palsy","AIM-High","Inclusion Criteria (High Risk Group) :\n\n* Legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol.\n* All infants considered high risk for a diagnosis of cerebral palsy and neuro-developmental impairment will be eligible, specifically including:\n\n  * All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight\n  * All encephalopathic infants\n  * Neurological risk factors (e.g., cerebral birth defect, injury\u002Fmalformation on neuroimaging, persistently abnormal neurological exam)\n\n(Control Group)\n\n-A control arm will also be recruited.\n\nExclusion Criteria:\n\n* Death prior to discharge from the neonatal unit (High-Risk Infants only)\n* No parental consent (High-Risk and Control Infants)",true,"ALL","0 Days","4 Months",{"count":22,"type":23},600,"ESTIMATED","30 Months","OBSERVATIONAL","Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated issues with their motor skills. Some newborns are at higher risk of developing CP, including babies born prematurely, those who have an injury to their brain, and those who have an abnormal neurological examination. However, most babies with a higher risk of CP do not develop CP. The problem is that doctors can't tell early on who will and who will not develop CP, they can only say who has a risk of it. Therefore, these babies are followed up in out-patient clinics to see how they are progressing, usually by a neonatologist (baby doctor), often a physiotherapist, and some may also be referred to services in the community like the Early Intervention Team. If there is a significant concern, doctors will often perform a scan of the baby's brain to provide more information. Even with all this follow-up, it still usually takes at least 12 months, and can be up to 2 years, to diagnose a child as having CP.\n\nIn this study the aim is to try and reduce the age of diagnosis of CP by assessing children in high-risk out-patient clinics using novel and specific examinations. We would also like to improve our ability to predict who will need help with learning, language or other non-motor outcomes. This study is being conducted at several hospitals in Ireland, including Cork University Maternity Hospital (CUMH), The Rotunda Hospital and the Coombe Women and Infants Hospital. It is being coordinated by the In4kids network and will be conducted in the INFANT Centre\u002F University College Cork (UCC). The study has been funded by Research Ireland and the Cerebral Palsy Foundation, USA.",[28,29,30,31,32,33,34,35,36,37],"Cerebral Palsy","Cerebral Palsy (CP)","Cerebral Palsy Children","High-risk Infants","Intellectual and Developmental Disabilities","Motor Impairment","Cognitive Development","HIE - Hypoxic - Ischemic Encephalopathy","Preterm","Prematurity; Extreme",[28,39,40,41,42,43,44],"High-Risk Infant Follow-up","Motor Difficulty","Intellectual Delay","Cognitive Impairment","Hypoxic--Ischaemic Encephalopathy","Prematurity","RECRUITING","2026-05-08",{"date":48,"type":49},"2026-05-13","ACTUAL",{"date":51,"type":49},"2025-03-21",{"date":53,"type":23},"2030-07-31",{"name":55,"class":56},"University College Cork","OTHER",4,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":18,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":77,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100385104","targeted-fortification-of-donor-breast-milk-in-preterm-infants-100385104","NCT04294368","Targeted Fortification of Donor Breast Milk in Preterm Infants","Inclusion Criteria:\n\n* Premature infants born \\\u003C\u002F= 30 weeks gestational age\n* Birth Weight \\\u003C\u002F= 1500 grams\n\nExclusion Criteria:\n\n* Parents do no consent to donor milk\n* Confounders for poor growth such as congenital heart disease, GI diagnoses such as gastroschisis and omphalocele, and or major congenital anomalies\n* Grade III or IV intraventricular hemorrhage diagnoses prior to randomization\n* Small for gestational age (\\\u003C3% on Fenton Growth Curve)\n* Failure to initiate fortified feeds prior to 3 weeks of life\n* Diagnosis of necrotizing entercolitis prior to randomization\n* Diagnosis of early onset sepsis confirmed with positive culture","1 Day","21 Days",{"count":67,"type":23},50,"INTERVENTIONAL",[70],"NA","This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.",[37,73,74,75,76],"Failure to Thrive in Newborn","Growth Retardation","Growth Failure","Infant Nutrition Disorders",[78,79,80,81,82],"Human Milk Analyzer","Miris","Target Fortification","Targeted Fortification","Donor Breast Milk","2026-04-01",{"date":85,"type":49},"2026-04-07",{"date":87,"type":49},"2020-03-09",{"date":89,"type":23},"2027-03",{"name":91,"class":56},"Columbia University",1,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":104,"conditions":105,"keywords":110,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100607733","health-related-quality-of-life-and-household-financial-and-wellbeing-impacts-of-prematurity-and-necrotising-enterocolitis-nec-100607733","NCT07192393","Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).","Quantifying the Household Impact on Patient-Reported Outcomes and Costs Associated With the Care of Preterm Babies With and Without Necrotising Enterocolitis (NEC): A Study Alongside the Withholding Enteral Feeds Around Blood Transfusion (WHEAT) Trial","PREM-IMPACT","Inclusion Criteria:\n\n* Preterm birth \\\u003C30 gestational weeks\n\nExclusion Criteria:\n\n* Parent(s) of a preterm baby who died of necrotising enterocolitis (NEC)\n* Parent(s) unwilling or unable to provide written informed consent\n* Parent(s) and sibling(s) unable to understand English.","30 Weeks",{"count":103,"type":23},90,"PREM-IMPACT is a UK-based observational study exploring how caring for a very premature baby-particularly one affected by necrotising enterocolitis (NEC)-impacts families over the first year after hospital discharge. NEC is a serious bowel disease that can occur in premature babies, often requiring surgery and prolonged hospitalisation.\n\nThis study runs alongside the WHEAT International Trial, which investigates whether pausing or continuing milk feeds during blood transfusions affects the risk of NEC in very preterm babies. PREM-IMPACT acts as a nested economic evaluation of the WHEAT Trial, helping to understand whether different feeding practices around transfusion offer good value for money from both the NHS and family perspective.\n\nPREM-IMPACT will collect detailed data on babies' health-related quality of life, as well as the financial, emotional, and social impact on parents and siblings. Families are recruited from neonatal units when their baby is ready to go home and complete questionnaires at three timepoints: 1) just before discharge, 2) six months later, and 3) twelve months later. Questionnaires cover health, wellbeing, healthcare use, and costs to the family (such as travel, time off work, or extra care needs). A dedicated research nurse based at the lead NHS site helps coordinate follow-up centrally.\n\nBy studying families of babies with and without NEC, this project aims to clarify the burden of prematurity and NEC on infant outcomes and family wellbeing. The results will inform future policy decisions, including whether pausing or continuing milk feeds during transfusion should be adopted in routine neonatal care.",[37,106,107,36,108,109],"Prematurity; Decision Support","Necrotising Enterocolitis","Preterm Birth","Preterm Infant Health",[111,112,113,114,115,44,36,116,117,118],"NEC","Cost-Effectiveness Analysis","Cost-Utility Analysis","Health-Related Quality of Life","HR-QoL","Health Economic Analysis","Financial Impact","Wellbeing","2026-03-27",{"date":121,"type":49},"2026-03-30",{"date":123,"type":49},"2025-08-08",{"date":125,"type":23},"2027-10-31",{"name":127,"class":56},"Imperial College London",7,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":17,"sex":18,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":92},"100371289","pulmonary-vascular-disease-and-cardiac-performance-in-extreme-preterm-infants-100371289","NCT04114435","Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants","Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants: A Prospective Cross-sectional Study","Inclusion Criteria:\n\n* Infants born at \\\u003C29 weeks' gestational age admitted to the NICU\n* All infants born at \\\u003C29 weeks' gestational age followed at MCH clinic after an admission in the NICU for prematurity \\\u003C29 weeks\n\nExclusion Criteria:\n\n* Congenital heart disease (except an atrial (ASD) or ventricular septal defect (VSD), or a patent ductus arteriosus (PDA))\n* Congenital severe lung or airway malformation (choanal atresia, trachea-esophageal fistula or congenital pulmonary airway malformation)\n* Genetic disorder (Trisomy 21).","7 Days","5 Years",{"count":139,"type":23},150,"Pulmonary vascular disease and cardiac performance in extreme preterm infants: A prospective cross-sectional study",[37],"2025-06-12",{"date":144,"type":49},"2025-06-17",{"date":146,"type":49},"2019-10-12",{"date":148,"type":23},"2025-12",{"name":150,"class":56},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":68,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":92},"100558932","prophylactic-surfactant-by-thin-endotracheal-catheter-for-preterm-infants-at-birth-the-protect-trial-100558932","NCT06557551","Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial","proTeCt","Inclusion criteria\n\n* Infants of any sex born before 28 weeks of gestation\n* Clinicians plan to provide intensive care\n* Consent for their participation provided by parent(s)\u002Fguardian(s) before their birth\n\nExclusion criteria\n\n• Major congenital anomalies (e.g. upper airway anomaly, diaphragmatic hernia, gastroschisis, exomphalos major, intestinal atresias, open neural tube defect, aneuploidy, cardiac lesions other than ASD\u002FPFO\u002FVSD\u002FPDA )","30 Minutes",{"count":160,"type":23},164,[70],"The goal of this clinical trial is to learn whether giving surfactant through a thin endotracheal catheter to extremely premature babies shortly after birth reduces the number of them who are ventilated in the first 3 days of life.\n\nThe main question it aims to answer is:\n\nDo fewer babies who receive prophylactic thin catheter surfactant under video laryngoscopy shortly after birth go on to be ventilated within 72 hours of birth?\n\nExtremely premature babies who are receiving breathing support through a face mask will either:\n\n* Receive surfactant through a thin catheter that is inserted into their windpipe (trachea) under video laryngoscopy at or after 5 minutes of life, have the catheter removed immediately, and return to face mask breathing support; or\n* Continue on face mask breathing support.\n\nAll babies will be closely watched to see whether they are ventilated for breathing support in the first 72 hours of life.",[164,44,37,165],"Infant, Newborn, Diseases","Respiratory Distress Syndrome in Premature Infant","2024-10-08",{"date":168,"type":49},"2024-10-15",{"date":170,"type":49},"2024-08-19",{"date":172,"type":23},"2027-02-28",{"name":174,"class":56},"University College Dublin"]