[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"necrotizing-enterocolitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:necrotizing-enterocolitis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,44,73,103,131,159,179,209,232,257,286,313,346],{"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":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100636155","investigation-of-allergen-sensitization-in-newborn-babies-diagnosed-with-necrotizing-enterocolitis-100636155",false,"NCT07562009","Investigation of Allergen Sensitization in Newborn Babies Diagnosed With Necrotizing Enterocolitis.","Allergy Risk and Sensitization Following Necrotizing Enterocolitis","AlisNEC","Inclusion Criteria:\n\n1. Infants born in our hospital and diagnosed with NEC during the study period.\n2. Age-matched control infants born in our hospital during the same period but without NEC diagnosis.\n3. Written and verbal informed consent obtained from at least one parent.\n\n   \\-\n\nExclusion Criteria:\n\n1. Infants whose parents did not provide written or verbal consent.\n2. Infants with major congenital anomalies.\n3. Infants with chromosomal disorders.\n4. Infants with gastrointestinal malformations (e.g., duodenal atresia, gastroschisis, omphalocele).\n5. Infants diagnosed with immunodeficiency. -",true,"ALL","12 Months","24 Months",{"count":22,"type":23},130,"ESTIMATED","INTERVENTIONAL",[26],"NA","To evaluate the frequency of allergy between 12 and 24 months of age in infants who were treated in the neonatal clinic and had NEC. To investigate the relationship between NEC development and the development of allergy in the later period.",[29,30,31],"Necrotizing Enterocolitis","Allergy","Preterm","NOT_YET_RECRUITING","2026-04-24",{"date":35,"type":36},"2026-05-01","ACTUAL",{"date":38,"type":23},"2026-04-01",{"date":40,"type":23},"2028-01-01",{"name":42,"class":43},"Saglik Bilimleri Universitesi","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":24,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100455687","withholding-enteral-feeds-around-blood-transfusion-international-100455687","NCT05213806","WithHolding Enteral Feeds Around Blood Transfusion (International)","The WHEAT International Trial: WithHolding Enteral Feeds Around Red Cell Transfusion to Prevent Necrotizing Enterocolitis in Preterm Neonates: an International, Multi-centre, Randomized Controlled Trial","WHEAT","Inclusion Criteria:\n\n1\\. Preterm birth at \\\u003C30+0 gestational weeks + days\n\nExclusion Criteria:\n\n1. Parent(s) opt-out of trial participation.\n2. Packed red cell transfusion with concurrent enteral feeds prior to enrolment. (Infants who have received a packed red cell transfusion while nil-by-mouth are eligible; or minimal enteral nutrition (\\\u003C15 ml\u002Fkg\u002Fday feeds) at the time of transfusion; defined as before, during and for at least 4 hours after transfusion, are eligible.\n3. Infants who are not being fed at the time of randomization (\\\u003C15ml\u002Fkg) or where enteral feeding is contraindicated \\[e.g. Major congenital abnormality of the gastrointestinal tract (GIT)\\].\n4. Previous episode of NEC Bell stage 2 or higher or SIP prior to first study packed cell transfusion.","30 Weeks",{"count":54,"type":23},4333,[26],"The WHEAT International trial is a comparative effectiveness trial exploring whether withholding enteral feeds around the time of blood transfusion in very premature infants (\\\u003C30 weeks) will reduce the occurrence of Necrotizing Enterocolitis (NEC). Currently both continued feeding and withholding feeding are approved care practices. The current study will randomize infants from Neonatal Intensive Care Units (NICUs) across Canada and the United Kingdom (UK) into one of the two care approaches (withholding or continued feeds) to determine if any significant outcomes are found.",[29],[59,29,60,61,62],"Comparative Effectiveness Trial","Premature Infants","Blood Transfusion","Withholding enteral feeds","RECRUITING","2026-04-21",{"date":33,"type":36},{"date":67,"type":36},"2022-01-28",{"date":69,"type":23},"2027-03-31",{"name":71,"class":43},"IWK Health Centre",40,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":18,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100633434","pattern-and-outcome-of-neonatal-gastrointestinal-emergencies-in-assiut-university-children-hospital-100633434","NCT07526636","Pattern And Outcome Of Neonatal Gastrointestinal Emergencies In Assiut University Children Hospital","Pattern And Outcome Of Neonatal Gastrointestinal Emergencies In Assiut University Children Hospital: A Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Neonates aged 0-28 days (corrected age if preterm)\n* Admitted to the NICU with a clinical diagnosis of a gastrointestinal emergency requiring urgent intervention\n* Written informed consent obtained from parent(s) or legal guardian(s)\n\nExclusion Criteria:\n\n* Other gastrointestinal problems not requiring urgent intervention","1 Minute","28 Days",{"count":83,"type":23},120,"OBSERVATIONAL","This prospective observational study aims to evaluate the pattern, clinical presentation, complications, and short-term outcomes of neonates admitted with gastrointestinal emergencies to the NICU at Assiut University Children Hospital. Data will be collected from admission through discharge, including demographic, antenatal, natal, clinical, nutritional, laboratory, and radiological information, to identify the most common emergencies and factors associated with adverse outcomes.",[29,87,88,89],"Intestinal Atresia","Malrotation","Hirschsprung Disease",[91,92,93,94],"Neonate","NICU","Gastrointestinal emergency","Intestinal obstruction","2026-04-09",{"date":97,"type":36},"2026-04-13",{"date":35,"type":23},{"date":100,"type":23},"2027-04-01",{"name":102,"class":43},"Assiut University",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":18,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":24,"phases":115,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":130},"100540353","phase-1-study-to-assess-the-safety-tolerability-and-preliminary-efficacy-of-st266-in-infants-with-necrotizing-enterocolitis-nec-100540353","NCT06315738","Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)","Randomized, Controlled, Phase 1-2 Open Label Study of ST266 IV Administration to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)","NEC","Inclusion Criteria:\n\n1. Infants born from ≥22 weeks gestational age up to and including 40 weeks gestational age; up to 40 weeks postmenstrual age (gestational age plus chronological age in terms of weeks) with current weight at diagnosis of NEC between ≥500g and ≤3000g, as a result of prematurity and\u002For IUGR. Parent(s)\u002Flegal medical representative(s) voluntarily provides written consent prior to study enrollment.\n2. Bell's Stage IIA or higher medical NEC (Stages IIA - IIIA only) diagnosis by radiologic confirmed pneumatosis intestinalis and may include intestinal dilation and ileus. The clinician confirms NEC diagnosis by evaluation of the radiologic imaging for confirmed pneumatosis intestinalis. If X-ray is used and is equivocal, an ultrasound (US) may be used, if available, to confirm pneumatosis. If the clinician (Neonatologist and\u002For Pediatric Surgeon) has differing interpretation from that of the Radiologist, that should be documented in both the medical and research records for accuracy of NEC diagnosis.\n\nExclusion Criteria:\n\n1. Infants with abdominal perforation.\n2. Not expected to survive ≥2 weeks or born with a lethal condition requiring hospice or palliative care (e.g., disease has progressed to NEC totalis, or patient has multi-organ system failure).\n3. Born with major congenital anomalies such as cardiac defects (e.g., Tetralogy of Fallot) or chromosomal disorders\u002Fanomalies (e.g., neural tube defect).\n4. Mother's receipt of any investigational product during pregnancy.\n5. Infants with malignancies (e.g., neoplastic cell growth as a solid tumor or a blood neoplasm, such as congenital leukemia).\n6. Infants with hypercoagulability disorders (any active thrombosis, diagnosis of disseminated intravascular coagulation or other acquired\u002Finherited disorders (i.e., hemophilia) of coagulation.\n7. Infants with a known immunodeficiency (such as galactosemia or agranulocytosis).\n8. Infants with anatomic defects that require surgical intervention.\n9. Infants with persistent pulmonary hypertension of newborn.\n10. Infants with any congenital or acquired gastrointestinal pathology that preclude feeds within 7 days after birth (e.g., duodenal atresia).\n11. Infants who have hypoxic ischemic injury (perinatal asphyxia).\n12. Infants with polycythemia (at time of treatment) (\\>22 g\u002FdL).\n13. Positive maternal human immunodeficiency virus status.\n14. History of maternal drug abuse (such as amphetamines, opiates, cocaine). This does not include marijuana, or prescription medications for treatment of drug abuse.\n15. Considered by the Investigator, for any reason, to be an unsuitable candidate for the study.\n16. Infants diagnosed with NEC who will require immediate surgical intervention.","2 Weeks","8 Weeks",{"count":114,"type":23},36,[116,117],"PHASE1","PHASE2","The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL\u002Fkg and 1.0 mL\u002Fkg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL\u002Fkg and 1.0 mL\u002Fkg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC.",[29],[29,109],"2026-04-07",{"date":97,"type":36},{"date":124,"type":36},"2024-08-19",{"date":126,"type":23},"2029-11",{"name":128,"class":129},"Noveome Biotherapeutics, formerly Stemnion","INDUSTRY",8,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100568431","study-of-normal-intestinal-development-and-disease-in-premature-and-term-neonates-100568431","NCT06681129","Study of Normal Intestinal Development and Disease in Premature and Term Neonates","Study of Normal Intestinal Development and Disease in Premature and Term Neonates - a Pathway for the Study of Premature and Neonatal Intestinal Disorders Including the Roles of Nutrition, Microbes, and Cellular Physiology, and Diseases Including Necrotizing Enterocolitis","NiiCE","Inclusion Criteria:\n\n* Any neonate or infant through 2 years of age having intestinal surgery or intestinal biopsies from an esophogastroduodenoscopy (EGD) or colonoscopy.\n\nExclusion Criteria:\n\n* Children \\> 2 years of age.\n* Infants 0-2 years old not undergoing GI surgery or intestinal scope with biopsy procedure.","2 Years",{"count":141,"type":23},100,"Current research on early intestinal development is primarily performed in mouse models. While useful in many other ways, mouse models are not ideal for studying human intestine development as the timing of this process differs between the two species. Further, prior research has demonstrated that some proteins and pathways that are critical in human development have no clear role in mice.\n\nThis study aims to improve the overall understanding of critical aspects of intestinal development in humans. In addition, this study will investigate the impact of intestinal diseases that are found in the early stages of life such as necrotizing enterocolitis (NEC).",[109,29,144,145],"Intestinal Disease","Human Development",[109,147,148,29],"Early Intestinal Development","Intestinal Intervention","2026-03-24",{"date":151,"type":36},"2026-03-27",{"date":153,"type":36},"2025-03-17",{"date":155,"type":23},"2034-12-31",{"name":157,"class":43},"Boston Children's Hospital",1,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":18,"minAge":165,"maxAge":81,"enrollmentInfo":166,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":4},"100592200","application-of-transcriptome-sequencing-combined-with-family-based-whole-genome-sequencing-in-improving-precise-diagnosis-of-critically-ill-newborns-in-northeast-china-100592200","NCT06990334","Application of Transcriptome Sequencing Combined With Family-Based Whole Genome Sequencing in Improving Precise Diagnosis of Critically Ill Newborns in Northeast China","Inclusion Criteria:\n\nCritically ill newborns under the age of 3 months. Suspected of having a genetic disease based on clinical manifestations (such as abnormal phenotypes) or family history.\n\nParents or legal guardians provide informed consent to participate in the study and agree to undergo rapid\u002Fultra-rapid WGS sequencing. In cases of negative results, further transcriptome sequencing will be conducted.\n\nExclusion Criteria:\n\nThe principal investigator deems the participant unsuitable for the study. Diseases caused by pregnancy, perinatal infection, ischemia, hypoxia, and other non-genetic factors.\n\nInability to fully cooperate with the study, affecting data integrity. The child already has a genetic diagnosis that fully explains the disease onset.","1 Day",{"count":167,"type":23},1000,"Background: Birth defects and genetic diseases are major threats to infant health. Many genetic diseases present atypically in newborns, who often have critical conditions, rapid progression, and high mortality. Early diagnosis is crucial but challenging. While next-generation sequencing (NGS) technologies like whole genome sequencing (WGS) and whole exome sequencing (WES) have significantly advanced genetic disease diagnosis, conventional WES\u002FWGS has a long detection cycle. Rapid\u002Fultra-rapid sequencing technologies (rWES\u002FurWES, rWGS\u002FurWGS) offer far-reaching clinical value.\n\nStudy Objective: This study aims to explore the application of transcriptome sequencing in clinically diagnosing neonatal genetic diseases with negative rWGS results, improve diagnostic rates, assist in early determination of disease causes, provide genetic counseling, and achieve targeted, personalized treatment guidance and prognosis evaluation.\n\nStudy Design: This is a multi-center cohort study led by the First Hospital of Jilin University, involving at least five clinical medical institutions. The planned sample size is 1,000 cases over three years. The study will include critically ill newborns under three months old, suspected of having genetic diseases based on clinical manifestations or family history, with informed consent from parents or legal guardians.\n\nMethods: The study will conduct RNA-seq and joint analysis on 1,000 critically ill newborns with negative family-based rWGS results. The goal is to improve the interpretation of variants of uncertain significance (VUS) and the gene-positive diagnostic rate. It will accumulate disease research big data and conduct integrative genomic analyses based on Pathway and protein-protein interaction (PPI) networks to discover potential new molecular genetic mechanisms and guide new treatment developments.\n\nData Management: Data will be promptly, completely, accurately, and clearly recorded in case report forms and entered into a database system. Data verification, cleaning, and archiving will follow strict procedures to ensure data quality and integrity.\n\nData Analysis: Bioinformatics analysis of sequencing data will include quality control, data filtering, sequence alignment, mutation annotation, variant screening, single-gene mode analysis, and joint transcriptome analysis. Statistical analysis will follow traditional clinical trial methods, with a focus on controlling biases and confounding factors.",[29],"2025-05-18",{"date":172,"type":36},"2025-05-25",{"date":174,"type":23},"2025-06-01",{"date":176,"type":23},"2028-12-31",{"name":178,"class":43},"The First Hospital of Jilin University",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":18,"minAge":186,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":190,"conditions":191,"keywords":194,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":158},"100574307","necrotizing-enterocolitis-and-bowel-perforation-in-very-preterm-infants---long-term-follow-up-100574307","NCT06757582","Necrotizing Enterocolitis and Bowel Perforation in Very Preterm Infants - Long-term Follow up","NOR-NEC","Inclusion Criteria:\n\n* Case: All Norwegian very preterm infants (gestational age (GA) \\\u003C 32 weeks) born during the 6-year period 2008-2013, diagnosed with surgical NEC or bowel perforation and surviving up to one year of age will be invited to participate as cases.\n* Controls: For each case we will invite two controls matched for important clinical characteristics (e.g. sex, GA, clinical illness score, intracranial pathology, need for oxygen at discharge etc.).\n\nExclusion Criteria:\n\n* not signing informed consent scheme","6 Years","15 Years",{"count":189,"type":23},150,"Necrotizing enterocolitis (NEC) is a gastrointestinal syndrome characterized by transmural inflammation and necrosis of the large and\u002For small bowel and subsequent intramural gas-forming organisms into the intestinal wall. Some preterm infants also develop spontaneous intestinal perforations (SIP) without the classical bowel inflammation\u002Fnecrosis seen in NEC. NEC and SIP can be challenging to differentiate. Severe cases of both conditions require surgery and often bowel resection, but mortality due to SIP seems lower.\n\nStudies looking at \"long-term prognosis\" of infants with NEC and bowel perforation have mainly assessed outcome until 2-7 years of age. The primary school years is a vulnerable period for ex-preterm children. Disruption in learning and social integration is of great importance for their quality of life (QoL), but little data exist in this age group. Moreover, nutritional deficits (e.g. cobalamin- or iron-deficiency may impact cognitive development, but this has not been investigated in this \"high-risk\" population in school age. Authors of a recent systematic review on gastrointestinal sequel after NEC-surgery thus called for \"more high-quality studies assessing long-term follow-up\".\n\nIn this project we will study the long-term impact of surgery for NEC and bowel perforation in preterm infants, both with a quality of life (QoL) perspective and with a focus on development, growth, nutrition and persistent gastrointestinal problems.",[29,192,193],"Intestinal Perforation","Premature Infant Disease",[195,196,197,198,199],"necrotizing enterocolitis","bowel perforation","preterm infant","long-term follow-up","quality of life","2025-01-02",{"date":202,"type":36},"2025-01-03",{"date":204,"type":23},"2025-02-01",{"date":206,"type":23},"2027-08-01",{"name":208,"class":43},"University Hospital of North Norway",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":24,"phases":218,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":158},"100460204","early-phase-1-prephage---faecal-bacteriophage-transfer-for-enhanced-gastrointestinal-tract-maturation-in-preterm-infants-100460204","NCT05272579","PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants","PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants - Clinical Trial","Inclusion criteria for participant preterm infants\n\n* Preterm infants born between GA 26+0 and 30+6\n* Delivery at RH or transferred to RH NICU within 24 hours of delivery\n* Children administered prophylactic antibiotics due to maternal risk factors, specifically: premature rupture of membranes, groub b streptococcus positive, feber during labour\n* Signed parental consent\n\nExclusion criteria for participant preterm infants\n\n* Major congenital anomalies or birth defects\n* Antibiotics for more than 72 hours after birthExtremely SGA infant (weight SD score \\\u003C -3 SD)\n* Need for mechanical ventilation or cardiovascular support before first FFT treatment\n\nInclusion criteria for mothers of participants\n\n* Women aged 18-45\n* Ability to give informed consent\n\nExclusion criteria for participant mothers\n\n● Mothers who have severe infection, defined by need for other treatment to support infection-related comorbidities, besides from antibiotics (e.g. inotropic treatment, iv fluid resuscitation)",{"count":217,"type":23},20,[219],"EARLY_PHASE1","PrePhage - Fecal bacteriophage transfer for enhanced gastrointestinal tract maturation in preterm infants\n\nThis pilot triol has the primary goal of demonstrating the safety of transferring viruses and proteins from healthy term infants to preterm infants born between gestational age (GA) 26 + 0 and 30+6. The long-term goal is to develop a safe and effective treatment to prevent the severe gut disease called necrotizing enterocolitis (NEC).\n\nNEC is a common disease in neonatal intensive care units affecting 5-10% of all admitted patients. 15-30% of the affected children die from the disease, and many of the survivors suffer from the effects of extensive gut surgery.\n\nWhile the disease is caused by many different factors, recent research has shown the gut microbiome to be a central factor in the development of NEC. Furthermore, in the recent years special viruses called bacteriophages have shown potential in the treatment of various diseases.\n\nBy collecting feces from healthy, term infants and filtering it thoroughly, the investigators can provide a treatment that contains practically only viruses, proteins and nutrients. It is our belief that giving the preterm infants a mix of viruses including bacteriophages will prevent NEC.\n\nTo do this, the investigators will go through 3 stages:\n\n1. Recruiting and following healthy donor infants to study the microbiota and use feces from them to donate in stage 2 and 3\n2. Examining the safety of the treatment as well as how it works in preterm piglets\n3. Testing the treatment in preterm infants. 10 preterm infants will receive the treatment and 10 preterm infants will receive placebo. The investigators expect to see no serious side effects to the treatment. The investigators hope, but do not expect to be able to see a beneficial effect of the treatment.\n\nIf this pilot trial shows promising results, it will be followed be a larger clinical trial.",[29,222],"Microbial Substitution","2024-11-13",{"date":225,"type":36},"2024-11-15",{"date":227,"type":36},"2023-11-07",{"date":229,"type":23},"2025-12-31",{"name":231,"class":43},"Rigshospitalet, Denmark",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":18,"minAge":165,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":24,"phases":240,"briefSummary":241,"conditions":242,"keywords":247,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":255,"locationsCount":158},"100567801","impact-of-standardized-skin-to-skin-care-on-clinical-outcomes-in-infants-born--32-weeks-a-multicenter-study-100567801","NCT06672913","Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study","TR-SSCinNICU","Inclusion Criteria:\n\n* Infants born at gestational age ≤ 32 weeks\n\nExclusion Criteria:\n\n* Death before NICU discharge\n* Abdominal wall defects",{"count":83,"type":23},[26],"This study is a multi-center, prospective pre-post clinical study conducted under the leadership of the Turkish Neonatal Society. It aims to investigate the effects of a standardized skin-to-skin care in NICU, initiated early and applied regularly, on recieving exclusive mothers' milk at discharge and clinical outcomes for preterm infants born ≤ 32 weeks of gestation.\n\n1. Primary Objective: To evaluate the rate of receiving exclusive mothers' milk at discharge for infants born ≤ 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol.\n2. Secondary Objective: To evaluate the rates of neonatal sepsis, intraventricular hemorrhage, and necrotizing enterocolitis (stage 2 and above) as well as the length of hospital stay for infants born at or below 32 weeks of gestation who have received skin-to-skin care in accordance with the study protocol.",[243,244,245,29,246],"Premature","Skin to Skin Contact","Breast Feeding","Retinopathy of Prematurity",[243,248,245,29,246],"Skin to skin contact","2024-11-01",{"date":251,"type":36},"2024-11-04",{"date":253,"type":36},"2024-09-01",{"date":174,"type":23},{"name":256,"class":43},"Baskent University Ankara Hospital",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":24,"phases":267,"briefSummary":268,"conditions":269,"keywords":273,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":158},"100481061","spectral-analysis-of-bowel-sounds-in-preterm-babies-of-less-than-32-weeks-of-amenorrhea-wa-as-predictive-factor-of-enterocolitis-100481061","NCT05544097","Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis","BHAPE","Inclusion Criteria:\n\n* preterm babies of less than 32WA\n\nExclusion Criteria:\n\n* preterm babies of more than 32WA,\n* digestive congenital malformation","32 Weeks",{"count":266,"type":23},50,[26],"The recording or bowels is easy and cheap. The investigators wonder if these sounds are modified in babies with high risk of necrotizing enterocolitis. In this study, the investigators suggest to record and do a spectral analysis of 30 seconds of bowel sounds in preterm babies of less than 32WA before and after enteral nutrition, every day until the end of hospitalization. A spectral analysis will be made for each record to determine frequencies of the signal. The investigators will try to determine physiological frequencies and look for modifications in pathological situations.",[270,271,29,272],"Bowel Sounds","Spectral Analysis","Preterm Babies",[274,275,29,276],"bowel sounds","spectral analysis","preterm babies","2024-07-09",{"date":279,"type":36},"2024-07-10",{"date":281,"type":36},"2022-09-06",{"date":283,"type":23},"2025-11",{"name":285,"class":43},"Centre Hospitalier Universitaire, Amiens",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":297,"conditions":298,"keywords":299,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":158},"100518602","qualitative-study-of-surgeons-with-prospective-patient-follow-up-100518602","NCT06032676","Qualitative Study of Surgeons With Prospective Patient Follow-up","Surgical Decision Making in Necrotising Enterocolitis - a Prospective Qualitative Study of Surgeons","NECqual","Inclusion Criteria:\n\n1. Infant with suspected or confirmed NEC undergoing review by surgeon, regardless of outcome of that review (I.e. surgery indicated or not).\n\n   Exclusion Criteria:\n2. Lack of consent from surgeon to undertake interview.\n3. Lack of consent from parents to follow-up outcomes of infant.","4 Months",{"count":296,"type":23},75,"Necrotising enterocolitis (NEC) is a devastating disease which causes severe bowel inflammation resulting in babies becoming critically unwell. It mainly affects premature babies (who can be born as early as 22 weeks) in the first few weeks of life. A quarter of babies don't respond to intensive care treatment and require surgery to remove bowel which has died to prevent them from getting sicker. Sadly, about a third of the most unwell babies don't survive and those that do have a high incidence of significant long-term health problems.\n\nDeciding which babies will benefit from surgery is challenging and there are no objective methods used to do this currently. Surgeons must weigh up the risks and benefits of performing major surgery on a tiny baby in the knowledge that surgery itself may cause harm. This uncertainty causes delays in performing surgery. Those that have a delay are more likely to have a poor outcome.\n\nIn order to improve these unfavourable outcomes it is essential to understand and define current practice in detail (i.e. indications and timing for surgery) and understand how this may be associated with outcome. These outcomes are both short term, including mortality and ability to tolerate enteral nutrition, and long term which include neurodevelopmental outcomes at 2 years of life.\n\nTo do this the investigators will undertake a multicentre mixed methods study with qualitative interview of consultant paediatric surgeons shortly after making a decision to operate, or not, on a baby with NEC. The investigators will then take consent from the parents\u002Fguardian of the infant to follow-up their clinical outcomes using data linkage to routinely collected data, within the national neonatal research database. Outcomes of interest include survival, feeding outcomes, further surgical procedures and neurodevelopment at 2 years.",[29],[300,301,302,303],"surgical decision making","neonatology","qualitative research","Necrotising enterocolitis","2024-04-16",{"date":306,"type":36},"2024-04-18",{"date":308,"type":36},"2024-01-01",{"date":310,"type":23},"2028-10-01",{"name":312,"class":43},"University Hospital Southampton NHS Foundation Trust",{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":18,"minAge":321,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":24,"phases":325,"briefSummary":326,"conditions":327,"keywords":332,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":158},"100485728","probiotic-supplementation-in-extremely-preterm-infants-in-scandinavia-100485728","NCT05604846","Probiotic Supplementation in Extremely Preterm Infants in Scandinavia","Probiotic Supplementation in Extremely Preterm Infants in Scandinavia: A Double-blinded Randomized Controlled Multicenter Trial to Reduce the Risk of Necrotizing Enterocolitis and Mortality","PEPS","Inclusion Criteria:\n\n-All extremly preterm infants born beween gestational age 22+0 to 27+6\n\nExclusion Criteria:\n\n* Patients with severe complications and low chance of survival detected wihin the first 72 hours of life\n* Patients with major congenital-anomalies\n* Patients included in other interventional trials with the same or overlapping oucome measures.","22 Weeks","28 Weeks",{"count":324,"type":23},1600,[26],"The primary aim of this research is to determine whether supplementation with probiotics during the first weeks of life reduces the risk of necrotizing enterocolitis (NEC) and neonatal mortality and is safe to use among extremely preterm (EPT) infants born before gestational week 28.\n\nP: The study population include EPT infants (n= 1620) born at six tertiary neonatal units in Sweden and four units in Denmark.\n\nI: This is a double-blinded multicenter randomized controlled trial where infants in the intervention group will as soon as they tolerate 3 mL breastmilk per feed receive a probiotic combination of Bifidobacterium infantis, Bifidobacterium lactis, and Streptococcus thermophilus diluted in 3 mL breastmilk and given once daily until gestational week 34.\n\nC: The control group will receive 3 mL breastmilk without probiotic supplementation (blinded) daily.\n\nO: Primary outcome variables is a composite endpoint of incidence of NEC and mortality. Secondary outcomes include incidence of sepsis, duration of hospital stay, use of antibiotics, feeding tolerance, growth, and body composition after hospital discharge.\n\nPatient benefit: To provide evidence on the usage of probiotics among EPT infants that are not currently covered by clinical recommendations. As EPT infants have the highest risk for NEC and mortality our results have the potential to change current recommendations and improve patient outcomes, decrease mortality, shorten hospitalization, and decrease overall health-care costs.",[29,328,329,330,331],"Death","Sepsis Newborn","Feeding Disorder Neonatal","Growth Acceleration",[333,109,334,335],"Probiotics","Extreme prematurity","Feeding tolerance","2023-10-13",{"date":338,"type":36},"2023-10-16",{"date":340,"type":36},"2022-12-16",{"date":342,"type":23},"2026-12",{"name":344,"class":345},"Region Stockholm","OTHER_GOV",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":356,"conditions":357,"keywords":363,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":369,"leadSponsor":371,"locationsCount":4},"100519559","pufas-in-preterm-infants-100519559","NCT06045130","PUFAs in Preterm Infants","Characteristics of PUFAs Composition in Preterm Infants and Its Impact on Disease Prognosis","PIPI","Inclusion Criteria:\n\nInfants born between 24 and 36 weeks of gestational age who are admitted within 24 hours of birth, including both premature and full-term newborns.\n\n\\-\n\nExclusion Criteria:\n\nInfants with severe congenital developmental abnormalities, those requiring external supplementation of PUFAs in addition to standard intravenous nutrition and breastfeeding, and those with a severe prognosis indicating non-survival during their hospitalization.\n\n\\-",{"count":355,"type":23},600,"The research endeavors to examine the critical composition of Polyunsaturated Fatty Acids (PUFAs) in premature infants across different gestational stages and under varying disease conditions, and delineate the metabolic attributes of PUFAs in premature infants and their interplay with the onset of diseases. This study anticipates furnishing a theoretical foundation for the rationalization of PUFAs supplementation in premature infants and for informing strategies related to disease prevention and management.",[29,358,359,360,361,362],"Intraventricular Hemorrhage","BPD - Bronchopulmonary Dysplasia","Sepsis","Periventricular Leukomalacia","Patent Ductus Arteriosus",[364],"PUFAs","2023-09-13",{"date":367,"type":36},"2023-09-21",{"date":367,"type":23},{"date":370,"type":23},"2026-08-31",{"name":178,"class":43}]