[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prematurity-complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prematurity-complications":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,74,107,149,182],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100644121","phase-1-gut-permeability-and-microbiome-in-preterm-infants-100644121",false,"NCT07667049","Gut Permeability and Microbiome in Preterm Infants","Gut Permeability and Microbiome in Very Low Birth Weight Preterm Neonates.","Inclusion Criteria:\n\n\\\u003C5 days Gestational age 24-32 weeks\n\nExclusion Criteria:\n\nNonviable or planned withdrawal of care\n\n* Significant GI dysfunction (e.g. heme-positive stools, abdominal distension (girth \\>2 cm baseline), or bilious emesis\u002F aspirates.\n* Triplet or higher order multiple\n* Severe asphyxia\n* Lethal chromosome abnormalities\n* Cyanotic congenital heart disease\n* Intestinal atresia or perforation\n* Abdominal wall defects\n* Known galactosemia or other galactose intolerance","ALL","4 Days",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1",": NEC, a life-threatening, GI emergency characterized by increased IP, affects approximately 7 to 10% of preterm neonates, and typically occurs within 7 to 14 days of birth (37, 38) with mortality as high as 30-50% (39). NEC symptoms mainly involve GI dysfunction, such as abdominal distension and feeding intolerance, but the presentation can be non-specific with few warning signs. Current therapies may be invasive, including surgical interventions that are often ineffective due to the rapid progression of the disease. Prematurity is the greatest risk factor for development of NEC (40, 41), due to physiological immaturity of the GI tract and altered levels of the normal GI microbiota. Several studies suggest that the initiation of an intense systemic and local inflammatory cascade leads to intestinal necrosis (42-47). Antenatal exposure to infection\u002Finflammation may predispose the developing intestinal mucosa to subsequent injury or dysregulated inflammatory responses. Previous studies have linked presence of amniotic fluid infection\u002Felevated cytokines, (48) cord blood cytokines, (49, 50) and umbilical cord inflammation (51) with risk for NEC in preterm neonates. In a rat model of NEC, maternal prenatal exposure to microbial LPS led to increased frequency and severity of intestinal injury (52). Taken together, these observations suggest that intestinal injury may be initiated in utero and contributes to increased IP at birth in the preterm neonate. Many of the defense mechanisms present in the mature intestine, such as peristalsis and tight junctions between intestinal epithelial cells (37) are decreased in an immature intestine, and thus bacteria normally confined to the intestinal lumen are able to reach systemic organs and tissues. Bacterial translocation triggers the activation of an exaggerated inflammatory response, which leads to further epithelial damage. Our analysis of the initial cohort of 43 preterm infants, and others' previous studies have shown that IP is high at birth in preterms (\\\u003C33wk gestation) with a rapid maturation of the intestinal barrier over the first 2 weeks. However, in some infants, high IP persisted and\u002For recurred in association with altered levels of the normal microbiota (bacteria community composition). Specifically, we observed that (1) rapid maturation of intestinal barrier function, characterized by decreased IP, correlates with increased microbial community diversity (Figure 1), and most outstandingly, the increased abundance of beneficial bacteria Clostridiales (Figure 2); (2) Clostridiales is highly transcriptionally active and co-active with the probiotic bacterium Bifidobacterium; (3) neonatal factors, including early introduction of breast milk, shorter period of antibiotic exposure, and later gestational age, favor the early colonization of the gut microbiota by members of Clostridiales and Bifidobacterium, which altogether are associated with improved intestinal barrier in preterm infants; (4) low Clostridiales spp. abundance (\\\u003C5%) and early gestational age (\\\u003C31.7wk) were identified to be the most discriminatory features for elevated IP by supervised learning scheme, reaching an accuracy of 86.1%. (5) Clostridiales and Bifidobacteriales are the most abundant bacteria groups in later stages (phase II\u002FIII at 6-18 months of age) as shown in Figure 2, suggesting a process of gaining prosperity of these two bacterial groups during intestine development after birth. Altogether our preliminary results suggest the early colonization of the natural occurring probiotics strains Clostridiales and Bifidobacterium strongly associate with rapid maturation of intestinal barrier function, and their measurement are highly promising for early detection and as potential nutritional supplement to prevent NEC in the high-risk preterm population. We propose in this study to recruit additional 150 mother-infant dyads (justified in study size analysis in research design), to address our hypothesis that the two naturally occurring beneficial bacteria Clostridiales and Bifidobacterium are rapidly gaining prosperity during normal intestine development in association with improved barrier function measured by La\u002FRh ratio. This continuation of the initial study builds on the previous findings that identified commensal bacteria Clostridiales and Bifidobacterium species as a strong indicator to the lowered IP and rapid maturation of intestinal barrier, to substantiate measurement of these probiotic strains combined with associated neonatal factors to form an accurate, rapid detection of intestinal permeability abnormality. We propose in this study to recruit additional 150 mother-infant dyads (justified in study size analysis in research design), to address our hypothesis that the two naturally occurring beneficial bacteria Clostridiales and Bifidobacterium are rapidly gaining prosperity during normal intestine development in association with improved barrier function measured by La\u002FRh ratio.",[26],"Prematurity Complications",[28,29,30,31],"Intestinal permeability","necrotizing enterocolitis","preterm infants","dual sugar probe test","NOT_YET_RECRUITING","2026-06-18",{"date":35,"type":36},"2026-06-24","ACTUAL",{"date":38,"type":20},"2026-07-15",{"date":40,"type":20},"2027-06-30",{"name":42,"class":43},"University of Maryland, Baltimore","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100643567","personalizing-preterm-neonatal-transfusions-with-fetal-hemoglobin-enriched-cord-blood-100643567","NCT07636473","Personalizing Preterm Neonatal Transfusions With Fetal Hemoglobin-Enriched Cord Blood","Advancing Neonatal Health: Personalizing Preterm Neonatal Transfusions With Fetal Hemoglobin-Enriched Cord Blood","ANH-Prestige","Inclusion Criteria:\n\n* Preterm neonates born between 24+0 and 31+6 weeks of gestational age;\n* Requirement for at least one red blood cell transfusion during hospitalization, according to current Italian transfusion thresholds;\n* Written informed consent obtained from parents or legal guardians prior to any study procedure.\n\nExclusion Criteria:\n\n* Gestational age \\> 32+0 weeks;\n* Pregnancy complicated by maternal-fetal alloimmunization (e.g., hemolytic disease of the newborn);\n* Pregnancy complicated by fetal hydrops;\n* Major congenital anomalies or genetic syndromes;\n* Previous red blood cell transfusions (prior to enrollment);\n* Perinatal hemorrhage at delivery;\n* Documented congenital infections (TORCH).","24 Weeks","31 Weeks",{"count":55,"type":20},200,[57],"NA","Long-term morbidities among very low birth weight infants remain a significant challenge. Oxidative stress is a key factor in the pathogenesis of 'free radical (FR) diseases of prematurity,' including retinopathy of prematurity, bronchopulmonary dysplasia, necrotizing enterocolitis, and intraventricular hemorrhage. Red blood cell (RBC) transfusions are recognized as a contributing factor to FR-related diseases. RBCs contain adult hemoglobin (HbA), which has a lower affinity for oxygen. This characteristic increases oxygen delivery and tissue uptake, leading to a potentially harmful state of hyperoxia and over-generation of FRs. The strategy employs a multidisciplinary approach to evaluate the impact of cord blood transfusions in anemic newborns. Results will be assessed in relation to short- and long-term neonatal outcomes to determine the effectiveness of this new preventive strategy. Improving the current data are critical for setting action priorities for and monitoring progress",[26,60],"Anemia",[62,63,64],"Cord Blood red blood cells","transfusion","preterm newborns","2026-06-09",{"date":67,"type":36},"2026-06-11",{"date":69,"type":20},"2026-11-01",{"date":71,"type":20},"2029-11-01",{"name":73,"class":43},"University of Parma",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":83,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100639413","antenatal-vs-postnatal-transport-team-positioning-in-extremely-preterm-outborn-infants-100639413","NCT07580859","Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants","A Prospective French National Study of the Impact of Antenatal Versus Postnatal Positioning of a Neonatal Transport Team on Survival and Severe Neurodevelopmental Delay at Two Years in Outborn 23-28 Weeks Infants : outbornTRANSFER Study Protocol","OutbornTRANSF","Eligible for inclusion are infants for whom an antenatal call to the emergency medical service (SAMU) was initiated due to prematurity (imminent delivery and infant alive at the time of the call) and who:\n\n* Were born outside a level 3 maternity hospital (outborn birth) in mainland France\n* Have a gestational age at birth between of 23+0 - 28+6\n* Have parents who speak and understand French (required for telephone follow-up) To assess parent-related outcomes, parents will also be included in the study if their infant is eligible and if they have not objected to participation.\n\nInfants will not be included if one or both parents are unable to speak and understand French, if at least one of the parents is opposed to inclusion, if they had lethal congenital malformations or if they were born outside hospital (accidental premature home births).","0 Days","28 Months",{"count":85,"type":20},627,"OBSERVATIONAL","The extremely preterm outborn births (delivered in maternity units without on-site neonatal intensive care) are associated with lower survival and increased risk of severe neurodevelopmental impairment compared with inborn births (delivered in maternity units with on-site neonatal intensive care).\n\nThis project aims to assess the effect of the neonatal transport team (NNT) antenatal versus postnatal positioning on outborn survival without major neurodevelopmental sequelae at two years of corrected age (CA). A national, multicenter, observational cohort will be established over a two-year period, including all outborn births between 23+0-28+6 weeks' gestation in mainland France for which a NNT is deployed and who are alive at the moment of arrival of the NNT. 627 infants born outborn and their families will be followed until the child reaches two years of corrected age.\n\nStudy will examine quality of neonatal resuscitation, stability during transport, neonatal morbidity, parental mental health and quality of life, medico-economic outcomes for both families and the healthcare system and regional provision of care.\n\nIf parents agree to participate after receiving appropriate information, hospital records will be used to collect maternal and neonatal characteristics as well as morbidity data. Telephone follow-up will be conducted one month after discharge and then every six months until 2 years of corrected age (CA). Neurodevelopment at 2 years of corrected age will be assessed using the ASQ-3, completed by the parents.\n\nThrough a detailed understanding of the processes of resuscitation, stabilization and transport, our goal is to reduce unnecessary deaths and disability for children and families, including long-term economic costs. The recommendations for the care of outborn preterm infants and for the optimization of NNT resources will be developed.",[26,89,90],"Neurodevelopment Outcome","Prematurity",[90,92,93,94,95,96],"Outborn","Transport","Mortality","Cohort study","Neurodevelopment","2026-05-26",{"date":99,"type":36},"2026-05-28",{"date":101,"type":20},"2026-06",{"date":103,"type":20},"2030-09",{"name":105,"class":43},"Assistance Publique - Hôpitaux de Paris",1,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":115,"enrollmentInfo":116,"targetDuration":115,"studyType":86,"phases":4,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":106},"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":117,"type":20},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.",[120,121,26,122],"Preterm Infant Development","Preterm Infant Health","Premature Birth",[124,30,125,126,127,128,129,130,131,132,133,134,135,136,137,138],"prematurity","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","RECRUITING","2026-03-18",{"date":142,"type":36},"2026-03-24",{"date":144,"type":20},"2026-03-13",{"date":146,"type":20},"2056-03-13",{"name":148,"class":43},"University Hospital of Cologne",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":160,"conditions":161,"keywords":165,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":106},"100625829","retinopathy-of-prematurity---visual-function-and-retinal-structure-100625829","NCT07427719","Retinopathy of Prematurity - Visual Function and Retinal Structure","Children Treated for Retinopathy of Prematurity - Study of Visual Function and Retinal Structure","Inclusion criteria:\n\n* Patients treated for ROP with either laser or injection of A-VEGF.\n* Patients previously diagnosed with ROP but not treated for the condition.\n\nExclusion criteria:\n\n* Age below six years at date of examination.\n* A developmental level not compatible with performing the study examinations.\n* Patients born or treated outside Norway\n* Known ocular or systemic disease that can give structural or functional changes in the retina.","6 Years","20 Years",{"count":159,"type":20},140,"Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). This disease could lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) has become more common.\n\nIn this study, the researchers will explore whether treatment of ROP affects visual function and retinal development. To explore this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).",[162,26,163,164],"Retinopathy of Prematurity (ROP)","Cerebral Visual Impairment","Visual Field Defect",[166,167,168,169,170,171,172,90],"Retinopathy of Prematurity","Treatment","Laser","anti-vascular endothelial growth factor","Visual field defect","Cerebral visual impairment","Refractive errors","2026-02-16",{"date":175,"type":36},"2026-02-23",{"date":177,"type":20},"2026-04-01",{"date":179,"type":20},"2029-06-01",{"name":181,"class":43},"Oslo University Hospital",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":190,"sex":191,"minAge":192,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":213},"100604637","amniotic-fluid--the-preterm-gut-100604637","NCT07152106","Amniotic Fluid & the Preterm Gut","The Impact of Amniotic Fluid on the Development and Microbial Colonization of the Preterm Intestinal Tract: the AMFIBIE Study","AMFIBIE","Inclusion Criteria:\n\n* Maternal age ≥16 years\n* Written informed consent\n* Successful collection of amniotic fluid\n\nExclusion Criteria:\n\n* Pregnancies complicated by fetal congenital and\u002For chromosomal abnormalities.\n* Insufficient proficiency of Dutch or English language",true,"FEMALE","16 Years",{"count":194,"type":20},275,"Background:\n\nNecrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations. An important yet understudied contributor in the development of the gastrointestinal tract (GIT) is amniotic fluid (AF). Knowledge is lacking on the critical shifts that may occur in AF in extremely preterm birth. The aim of the current study is to assess the composition of AF using advanced biomedical techniques. Secondary objectives are to assess AF profiles of infants with chorioamnionitis (CAM) and\u002For fetal growth restriction (FGR), assess key metabolites across gestation, correlate AF profiles with neonatal outcomes, and explore associations with early gut microbiota.\n\nMethods:\n\nln this multicenter, prospective, cohort study, AF (\\~5 mL) will be collected from obstetric patients delivering their infants extremely preterm (gestational age (GA) 24+0\u002F7-27+6\u002F7 weeks, n=125), either during vaginal delivery or cesarean section (CS). Additionally, AF samples will be collected from a reference group (n=150), including early midtrimester (GA \\\u003C23+\u002F7 weeks), very early and moderate to late preterm (GA 28+0\u002F6-36+6\u002F7 weeks), and full-term pregnancies (GA 37+0\u002F7-41+6\u002F7 weeks). Thorough characterization of AF will be conducted, including microbial profiling and metabolomics. Microbiota profiling of neonatal fecal samples will be conducted to assess the association between AF and early neonatal gut colonization patterns.\n\nDiscussion and expected results:\n\nAF profiles associated with CAM and\u002For FGR in extremely preterm infants are expected to be identified, as well as relevant associations with neonatal health outcomes (including NEC and sepsis) and early neonatal gut colonization patterns. The current study will not only increase the understanding of the GIT development and the pathogenesis of NEC and sepsis but may also aid in the identification of high-risk infants. In the future, these findings may facilitate early targeted microbiota-based interventions to prevent disease progression and ultimately improve clinical outcomes.",[197,198,199,200,201,202,203,26],"Chorioamnionitis","Chorioamnionitis Affecting Fetus or Newborn","Necrotizing Enterocolitis of Newborn","Neonatal Sepsis, Early-Onset","Neonatal Sepsis, Late-Onset","Fetal Growth Restriction (FGR)","Preterm Birth Complication","2025-08-28",{"date":206,"type":36},"2025-09-03",{"date":208,"type":36},"2024-10-14",{"date":210,"type":20},"2027-10-14",{"name":212,"class":43},"Maxima Medical Center",2]