[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"preterm-infant-health\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:preterm-infant-health":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,91,116,158],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100639874","human-milk-concentrating-device-to-optimize-mothers-own-milk-100639874",false,"NCT07576972","Human Milk Concentrating Device to Optimize Mother's Own Milk","Noninferiority Evaluation of Human Milk Concentrating Device to Optimize Mother's Own Milk","NEOMOM","Inclusion Criteria:\n\n* Birth at 32 0\u002F7 to 34 5\u002F7 weeks' gestational age, with a birthweight above 1500 grams and receiving MOM\n* Enteral feeding must be initiated within 48 hours post-birth and the infant must meet the NICU's clinical guidelines for feed fortification\u002Fsupplementation.\n* Multiples are eligible and will be randomized to the same group since the intervention affects MOM preparation.\n\nExclusion Criteria:\n\n* Major congenital anomalies\n* Contraindication to receiving MOM\n* Feeds not started by 2 days post-birth\n* Fortification\u002Fsupplementation not ordered by 5 days post-birth,\n* Inadequate MOM for concentration\u002Ffortification within 5 days post-birth\n* Expected transfer to another hospital\n* Expected hospital discharge within 14 days post-birth\n* Enrollment in another intervention study with an intervention that could affect infant growth or mineral status\n* Infant with contraindications for use of the HMC device","ALL","32 Weeks","35 Weeks",{"count":21,"type":22},310,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is a randomized, non-inferiority clinical trial evaluating a human milk concentration (HMC) device in preterm infants. The trial compares outcomes in infants fed mother's own milk (MOM) concentrated using the HMC device to those receiving standard of care feeding with MOM supplemented with cow's milk-based fortifiers or formula.\n\nThe primary objective is to determine whether infants receiving HMC-concentrated MOM achieve growth and mineral status that are non-inferior to standard of care, as measured by growth velocity through 28 days of life or hospital discharge and serum phosphate levels at 14 days of life.\n\nSecondary objectives include assessment of clinical safety through evaluation of feeding tolerance, weight gain, and serum chemistries during the study period. The study will also evaluate the cost and resource utilization associated with feeding strategies by comparing preparation time, supply costs, total feeding costs, and overall neonatal intensive care unit (NICU) cost of care, including length of stay.",[28,29],"Preterm Infant Health","Premature Babies",[31,32,33,34,35,36],"Human Milk Concentration","NICU Feeding","Neonatal nutrition","Mother's on Milk","Human Milk","Preterm infants","NOT_YET_RECRUITING","2026-05-04",{"date":40,"type":41},"2026-05-08","ACTUAL",{"date":43,"type":22},"2026-09-01",{"date":45,"type":22},"2028-07-01",{"name":47,"class":48},"Mother's Milk is Best","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":69,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"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":60,"type":22},90,"OBSERVATIONAL","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.",[64,65,66,67,68,28],"Prematurity; Extreme","Prematurity; Decision Support","Necrotising Enterocolitis","Preterm","Preterm Birth",[70,71,72,73,74,75,67,76,77,78],"NEC","Cost-Effectiveness Analysis","Cost-Utility Analysis","Health-Related Quality of Life","HR-QoL","Prematurity","Health Economic Analysis","Financial Impact","Wellbeing","RECRUITING","2026-03-27",{"date":82,"type":41},"2026-03-30",{"date":84,"type":41},"2025-08-08",{"date":86,"type":22},"2027-10-31",{"name":88,"class":89},"Imperial College London","OTHER",7,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":98,"maxAge":58,"enrollmentInfo":99,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":49},"100607678","mechanisms-affecting-the-gut-of-preterm-infants-receiving-blood-transfusion-with-different-enteral-feed-interventions-100607678","NCT07191678","Mechanisms Affecting the Gut of Preterm Infants Receiving Blood Transfusion With Different Enteral Feed Interventions","MAGPIE-2","Inclusion Criteria:\n\n* Very preterm babies (born between 23 to \\\u003C30 weeks of gestational age ) in the WHEAT International trial\n* Written informed consent from parents\n\nExclusion Criteria:\n\n* Babies who are deemed too unstable to perform the non-invasive monitoring and the ultrasound scan measurements by the attending clinical team\n* Babies who have already developed Bells stage 2 NEC, had bowel surgery or congenital abdominal conditions such as congenital diaphragmatic hernia, gastroschisis and exomphalos","23 Weeks",{"count":100,"type":22},270,"MAGPIE-2 is a prospective observational study designed to investigate the physiological mechanisms linking blood transfusion and enteral feeding practices to gut perfusion and oxygenation in very preterm infants. The study is nested within the WHEAT International randomised controlled trial, which compares two standard care approaches: withholding versus continuing milk feeds during red blood cell transfusion. While WHEAT evaluates clinical outcomes such as necrotising enterocolitis (NEC), MAGPIE-2 focuses on the underlying physiological changes that may contribute to NEC development.\n\nNEC is a serious gastrointestinal condition affecting approximately 10% of extremely preterm infants and is associated with high mortality and long-term neurodevelopmental impairment. Previous observational studies have suggested a temporal link between blood transfusion and NEC onset, particularly when feeds are continued during transfusion. However, the mechanisms remain poorly understood.\n\nMAGPIE-2 will use non-invasive monitoring tools-near-infrared spectroscopy (NIRS) and Doppler ultrasound-to measure cerebral and splanchnic (gut) tissue oxygenation and superior mesenteric artery (SMA) blood flow. These measurements will be used to calculate the Splanchnic-Cerebral Oxygenation Ratio (SCOR), a validated marker of gut tissue perfusion and ischaemia. A reduction in SCOR may indicate compromised gut oxygenation, potentially contributing to NEC.\n\nThe study will recruit 270 infants (135 per arm) already enrolled in the WHEAT trial. Weekly measurements will be taken until 34 weeks corrected gestational age or discharge. Peri-transfusion monitoring includes continuous NIRS from 4 hours before to 4 hours after transfusion, and additional 2-hour recordings at approximately 24 and 48 hours post-transfusion. SMA Doppler assessments will be performed weekly.\n\nPrimary outcomes include changes in SCOR post-transfusion between the two feeding strategies. Secondary outcomes include changes in cerebral and splanchnic oxygenation, SMA blood flow velocities, and the impact of severe anaemia (pre-transfusion haemoglobin ≤80 g\u002FL) on these parameters. The study also includes an assessment of inter-operator variability in Doppler measurements.\n\nMAGPIE-2 aims to provide mechanistic insights that could inform safer transfusion and feeding practices in neonatal care, potentially reducing the incidence of NEC in this vulnerable population.",[103,70,104,28],"NEC - Necrotizing Enterocolitis","Preterm Babies",[70,106,66,67],"Necrotizing Enterocolitis","2026-03-26",{"date":109,"type":41},"2026-04-01",{"date":111,"type":41},"2025-11-03",{"date":113,"type":22},"2027-04-30",{"name":115,"class":89},"Imperial College Healthcare NHS Trust",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":124,"enrollmentInfo":125,"targetDuration":124,"studyType":61,"phases":4,"briefSummary":127,"conditions":128,"keywords":132,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":49},"100630687","neonatal-data-and-biobank-to-study-factors-influencing-development-in-preterm-infants-born-at-32-weeks-gestation-andor-1500-g-birth-weight-100630687","NCT07490912","Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at \u003C32 Weeks' Gestation and\u002For \u003C1500 g Birth Weight","Establishing a Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at \u003C32 Weeks' Gestation and\u002For \u003C1500 g Birth Weight","Neo-Life","Inclusion Criteria:\n\n* Preterm infants born \\\u003C32 weeks' gestational age and\u002For with a birth weight \\\u003C 1500 g\n* Informed consent of parents\u002F legal guardians\n\nExclusion Criteria:\n\n* none","18 Years",{"count":126,"type":22},1300,"The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants. Advances in neonatal care have significantly improved survival rates of infants born with a gestational age of less than 32 weeks and\u002For a birth weight below 1500 g. However, these infants remain at high risk for multiple complications affecting neurological, pulmonary, cardiovascular, renal, and other organ systems, which may lead to long-term morbidity and reduced quality of life. Identifying early risk and protective factors is therefore essential to improve outcomes and develop targeted interventions.\n\nThe primary objective of the project is the prospective and structured collection of clinical data as well as biological samples within a standardized interdisciplinary follow-up program for preterm infants. The study aims to identify biological, clinical, and environmental factors associated with the development and long-term outcomes of different organ systems.\n\nThe study population includes infants born with a gestational age of less than 32 weeks and\u002For a birth weight below 1500 g who receive care at the perinatal center of the University Hospital Cologne. Participation requires informed consent from the parents or legal guardians. There are no specific exclusion criteria. Participants will be followed within the established preterm follow-up program over several years, allowing longitudinal assessment of clinical outcomes and developmental trajectories. Primary outcome is survival without impairment (e.g. neurocognitive, pulmonal, cardiovascular, renal) at the age of 5 years. Secondary outcomes include duration of breastfeeding, nutritional status, body mass index, and parental stress and bonding. In addition, biological samples will be collected to enable the creation of epigenetic, gene expression, and cytokine profiles. These data will contribute to the identification of predictive biomarkers that may help stratify risk and guide individualized preventive or therapeutic strategies in preterm infants.\n\nBy combining comprehensive clinical data with biological samples in a dedicated data and biobank, the Neo-Life project aims to generate a valuable resource for translational research. The findings are expected to improve understanding of the mechanisms underlying organ development and long-term health in preterm infants and to support the development of early interventions that may prevent or mitigate adverse outcomes.",[129,28,130,131],"Preterm Infant Development","Prematurity Complications","Premature Birth",[133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148],"prematurity","preterm infants","very low birth weight infants","very preterm infants","gestational age \u003C32 weeks","Premature birth","\u003C32 weeks gestational age","very low birth weight","\u003C1500 g birth weight","database","biobank","preterm infant development","preterm infant health","preterm infant long-term outcome","prematurity complications","risk and protective factors of preterm infant development","2026-03-18",{"date":151,"type":41},"2026-03-24",{"date":153,"type":22},"2026-03-13",{"date":155,"type":22},"2056-03-13",{"name":157,"class":89},"University Hospital of Cologne",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":172,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":185},"100616468","pilot-study-effects-of-ccp-intervention-on-nicu-environment-and-preterm-infants-development-100616468","NCT07306000","Pilot Study: Effects of CCP Intervention on NICU Environment and Preterm Infants Development","Effects of Close Collaboration With Parents Intervention on NICU Care Environments and Long-term Development of Preterm Infants: a Pilot Study","Inclusion Criteria:\n\n* preterm infants born below 32 weeks of gestation and\u002For weighing \\\u003C 1500 g who receive long-term follow-up at each study site.\n\nExclusion Criteria:\n\n* the infant has any major anomalies\n* the infants are triplets or higher order\n* the infant's condition is critical and the survival is uncertain\n* the parents cannot understand the informed consent form in Korean or in Japanese","1 Hour","7 Days",{"count":168,"type":22},100,[25],"Close Collaboration with Parents intervention is an evidence-based educational intervention for the entire multi-professional staff of neonatal intensive care units (NICUs). The goal of the intervention is to strengthen partnership between staff and parents, enhance parental participation in infant care. There are no studies yet about the effects of the Close Collaboration with Parents intervention on the long-term neurodevelopment and socio-emotional development of very preterm infants and their interaction with their parents. Accordingly, a multicenter cluster randomized controlled trial is planned. Prior to initiating this large-scale study, it is essential to validate the measurement instruments. Therefore, a pilot study will be conducted to assess their feasibility and to determine the appropriate sample size.",[129,28],[173,174],"close collaboration with parents","family-centered care","2025-12-29",{"date":177,"type":41},"2025-12-31",{"date":179,"type":41},"2025-12-22",{"date":181,"type":22},"2028-12-31",{"name":183,"class":184},"Turku University Hospital","OTHER_GOV",3]