[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nec---necrotizing-enterocolitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nec---necrotizing-enterocolitis":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,59,90,115,144],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100053679","delayed-versus-immediate-cord-clamping-in-preterm-birth-100053679",false,"NCT07699666","Delayed Versus Immediate Cord Clamping in Preterm Birth","Early Neonatal Outcomes After Delayed Versus Immediate Cord Clamping in Preterm Birth: A Comparative Study From A Tunisian Tertiary Maternity Center","PREM-CORD","Inclusion Criteria:\n\n* Preterm neonates born at gestational age between 32 and 37 weeks\n* Live-born infants delivered in the study center\n* Singleton pregnancies\n* Parental consent obtained when applicable according to institutional ethical requirements\n\nExclusion Criteria:\n\n* Major congenital malformations or chromosomal abnormalities\n* Need for immediate advanced resuscitation at birth\n* Severe fetal distress requiring emergency obstetric intervention incompatible with protocol allocation\n* Placental conditions contraindicating delayed cord clamping (e.g., placental abruption with maternal instability, placenta previa bleeding, Placenta accreta spectrum)\n* Intra Uterin Growth Restriction with abnormal umbilical artery Doppler velocimetry","ALL","0 Days",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this study is to evaluate whether delayed cord clamping improves early neonatal outcomes compared with immediate clamping in preterm birth.\n\nPreterm infants are at higher risk of neonatal complications, and the timing of cord clamping may influence placental transfusion and neonatal adaptation after birth. Delayed cord clamping may increase blood volume, improve iron stores, and reduce some neonatal morbidities, while immediate cord clamping is still commonly practiced in many settings.\n\nIn this study, preterm newborns are assigned to either delayed or immediate cord clamping according to a predefined protocol. Early neonatal outcomes, including respiratory status, need for resuscitation, hemoglobin levels, and early morbidity and mortality, will be assessed.\n\nThe study is conducted in a tertiary maternity center in Tunisia.",[27,28,29,30,31,32,33,34],"Preterm Birth Complication","Neonatal Morbidity and Mortality","Cord Clamping","Delayed Cord Clamping","Anemia","NEC - Necrotizing Enterocolitis","Intraventricular Hemorrhage Neonatal","Respiratory Distress Neonatal",[36,37,38,39,40,41,42,43,44,45],"Delayed cord clamping","Immediate cord clamping","Preterm infants","Preterm birth","Umbilical cord clamping","Neonatal outcomes","Placental transfusion","Neonatal morbidity","Neonatal mortality","Tunisia","RECRUITING","2026-07-08",{"date":49,"type":50},"2026-07-13","ACTUAL",{"date":52,"type":50},"2025-10-02",{"date":54,"type":21},"2026-12-31",{"name":56,"class":57},"Faculty of Medicine of Tunis","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":4},"100635885","effect-of-rectal-administration-of-breast-milk-on-gut-microbiota-in-preterm-infants-100635885","NCT07558499","Effect of Rectal Administration of Breast Milk on Gut Microbiota in Preterm Infants","Effect of Rectal Administration of Human Milk on Gut Microbiota and Clinical Outcomes in Preterm Infants: A Randomized Controlled Study","premic","Inclusion Criteria:\n\nPreterm infants with a gestational age ≤32 weeks and birth weight ≤1500 g\n\nInfants without meconium passage within the first 48 hours of life\n\nInfants whose parents have provided written informed consent\n\nExclusion Criteria:\n\nnfants with major congenital anomalies\n\nInfants with gastrointestinal system anomalies\n\nInfants in whom administration of maternal breast milk is contraindicated\n\nInfants whose parents do not provide consent for participation\n\nInfants who die within the first 72 hours of life","22 Weeks","32 Weeks",{"count":70,"type":21},60,[24],"This study aims to evaluate the effect of rectal administration of maternal breast milk on gut microbiota development in preterm infants. Preterm infants are at increased risk of dysbiosis due to immaturity and limited enteral feeding in the early postnatal period. In this randomized controlled study, preterm infants will receive either rectal administration of maternal breast milk or normal saline. The primary objective is to compare gut microbiota composition between the two groups. The findings may provide insight into a novel and non-invasive strategy to support microbiota development in preterm infants.",[74,75,32],"Premature","Gut Microbiota Diversity and Composition",[77,78,79],"premature","gut microbiota","preterm morbidities","NOT_YET_RECRUITING","2026-04-22",{"date":83,"type":50},"2026-04-30",{"date":85,"type":21},"2026-06-15",{"date":87,"type":21},"2027-08-15",{"name":89,"class":57},"Zekai Tahir Burak Women's Health Research and Education Hospital",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":97,"enrollmentInfo":98,"targetDuration":100,"studyType":101,"phases":4,"briefSummary":102,"conditions":103,"keywords":104,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100634923","multidimensional-dynamic-early-warning-system-for-neonatal-necrotizing-enterocolitis-a-multicenter-clinical-study-100634923","NCT07545993","Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study","Construction of a Multidimensional Dynamic Early Warning System for Genetic-Immune-Inflammatory Disorders in Precision Prevention and Control of Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study","Inclusion Criteria:\n\n* Preterm infants with gestational age \\\u003C32 weeks\n* Admission to the neonatology department of the lead institution or participating institutions\n* Parental consent to participate in the study and approval for genetic testing using residual samples from routine blood draws.\n* Possession of complete perinatal and hospitalization records.\n\nExclusion Criteria:\n\n* Congenital malformations, well-defined clinical syndromes, or chromosomal abnormalities\n* Death within 7 days after birth or voluntary discharge\n* Patients with confirmed positive diagnosis of pathogenic genes and interpretable major clinical phenotypes\n* Only one case of identical multiple births was retained for analysis to avoid genetic background overlap","3 Months",{"count":99,"type":21},1050,"6 Months","OBSERVATIONAL","Necrotizing enterocolitis (NEC) is one of the most severe gastrointestinal emergencies in preterm infants, characterized by insidious onset, rapid progression, and high mortality. It can lead to serious adverse outcomes such as intestinal perforation, short bowel syndrome, and neurodevelopmental disorders, making it a critical condition that significantly impacts the survival quality and long-term prognosis of preterm infants.With the advancement of perinatal medicine in China, the survival rates of extremely low and very low birth weight infants have been continuously improving. NEC has become a critical bottleneck constraining the quality of care and long-term prognosis for preterm infants.\n\nPrevious studies have demonstrated that various perinatal and early postnatal factors, including gestational age, birth weight, infection, feeding methods, blood transfusion, mechanical ventilation, and antibiotic exposure, are associated with the occurrence of NEC. However, these clinical factors still fail to adequately explain the interindividual variations in NEC incidence risk and disease severity under similar clinical exposure conditions.Existing NEC prediction models primarily rely on static baseline variables for one-time risk assessment, lacking dynamic risk updates during hospitalization, and most are derived from single-center retrospective studies.\n\nWith the application of clinical exome sequencing (CES), the role of genetic factors in susceptibility to NEC has gradually attracted attention.The research team has previously conducted NEC risk gene screening based on CES, genetic burden analysis, and exploration of genetic-clinical factor interactions, suggesting that genetic information can provide important supplementation for NEC risk assessment.Meanwhile, dynamic changes in immune-inflammatory markers such as peripheral blood eosinophils, NLR, absolute neutrophil count, and platelet count may already exhibit abnormalities prior to the onset of NEC, providing repeatable, low-cost, and clinically available signals for early identification.Based on this, this study aims to establish a multidimensional dynamic early warning system for NEC integrating single-center preliminary genetic research foundations with multi-center retrospective\u002Fprospective validation resources. This initiative seeks to enhance the identification capability of high-risk individuals and provide evidence for subsequent precision prevention and control as well as stratified management.",[32],[105,106,107],"preterm","neonate","early warning system","2026-04-15",{"date":81,"type":50},{"date":108,"type":21},{"date":112,"type":21},"2029-12-31",{"name":114,"class":57},"Guangzhou Women and Children's Medical Center",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":126,"conditions":127,"keywords":131,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":58},"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","30 Weeks",{"count":125,"type":21},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.",[32,128,129,130],"NEC","Preterm Babies","Preterm Infant Health",[128,132,133,134],"Necrotizing Enterocolitis","Necrotising Enterocolitis","Preterm","2026-03-26",{"date":137,"type":50},"2026-04-01",{"date":139,"type":50},"2025-11-03",{"date":141,"type":21},"2027-04-30",{"name":143,"class":57},"Imperial College Healthcare NHS Trust",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":150,"sex":17,"minAge":4,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":4},"100610884","assessing-the-efficacy-of-probiotics-in-prevention-of-nec-in-preterm-babies-100610884","NCT07233382","Assessing the Efficacy of Probiotics in Prevention of NEC in Preterm Babies","Inclusion Criteria:\n\n* Male and female preterm infants with a gestational age less than 35 weeks.\n* All indoor patients and outdoor patients who present within 24hrs of birth\n\nExclusion Criteria:\n\n* • Infants with congenital or developmental gastrointestinal disorders for example omphalocele, malrotation, gastroschisis.\n\n  * Infants with severe sepsis or gastrointestinal bleeding on presentation",true,"1 Day",{"count":153,"type":21},196,[24],"The goal of the study is to check efficacy of probiotics in preventing necrotizing enterocolitis. The main questions would be if the preterm baby developed NEC or not.",[128,32],"2025-11-28",{"date":159,"type":50},"2025-12-05",{"date":161,"type":21},"2025-12-01",{"date":163,"type":21},"2026-05-30",{"name":165,"class":166},"Hayatabad Medical Complex","OTHER_GOV"]