[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"very-preterm-infant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:very-preterm-infant":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100596467","effects-of-enteral-feeding-regimens-on-nec-mortality-and-neurodevelopment-in-very-preterm-infants-100596467",false,"NCT07045844","Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants","The Effects of Different Enteral Feeding Regimens on Necrotizing Enterocolitis, Mortality, and Neurodevelopment in Very Preterm Infants: A Multicenter Double-Randomized Trial","Inclusion Criteria:\n\n* Gestational age at birth less than 29 weeks;\n* No contraindications to enteral feeding;\n* Mother is willing to breastfeed.\n\nExclusion Criteria:\n\n* For Randomization Group 1: If the infant has already received pasteurized human donor milk (pHDM), preterm formula (PTF), or nutritional fortifiers;\n* For Randomization Group 2: If the infant is exclusively fed with preterm formula and the mother has no intention to express breast milk;","ALL","1 Day","14 Days",{"count":20,"type":21},2324,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born before 29 weeks of gestation. It also aims to assess whether routine use of human milk fortifiers benefits this population. The main questions it aims to answer are:\n\nDoes supplementing OMM with pHDM or PTF improve survival without surgery-requiring necrotizing enterocolitis (NEC) by 34 weeks corrected gestational age? Is routine fortification of human milk better than selective fortification based on growth faltering?\n\nResearchers will compare:\n\npHDM vs. PTF to see which better supports survival without severe NEC. Routine fortification vs. selective fortification to assess the impact on growth and long-term neurodevelopment.\n\nParticipants will:\n\nBe randomized twice:\n\n* First, within the first week of life to receive either pHDM or PTF when OMM is insufficient\n* Second, in the second week of life to receive either routine fortification or selective fortification only if growth faltering occurs Receive feeding and care as per standard clinical practice Complete neurodevelopmental assessment at 2 years corrected age using the PARCA-R tool (no additional study visits required) This multicenter, double-randomized, open-label randomized controlled trial is embedded in routine neonatal care and uses real-world data to assess both short- and long-term outcomes.\n\nCOLLABORATE-China is being run in partnership with the UK-wide COLLABORATE trial sponsored by Imperial College London.",[27,28],"Very Preterm Infant","Necrotizing Enterocolitis (NEC)","NOT_YET_RECRUITING","2026-02-22",{"date":32,"type":33},"2026-02-24","ACTUAL",{"date":35,"type":21},"2026-03-02",{"date":37,"type":21},"2030-07-31",{"name":39,"class":40},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",22,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":4,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100574944","lift-up-randomized-controlled-trial-of-fortification-of-human-milk-100574944","NCT06765863","LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk","Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP): Randomized Controlled Trial of In-facility Fortification of Human Milk in India","LIFT-UP RCT","Inclusion Criteria:\n\n* Very LBW (≤1.5kg)\\* or very preterm (≤32 weeks) infants admitted to NICU at study facility within 24 hours of birth for in-born infants and up to 48 hours for out-born\\*\\*\n* Mother and infant alive during screening\n* Mother age 18+ years\n* Lives within catchment areas of the facility\n* Mother intends to stay in catchment area of the study facility for at least 3 months\n* At randomization: Infant receiving at least 60 mL\u002Fkg\u002Fday of human milk\\*\\*\\*\n\nExclusion Criteria:\n\n* Lives outside the defined catchment area\n* Congenital abnormalities or acquired conditions that interfere with feeding or placement of nasogastric\u002Forogastric tube \\[cleft lip\u002Fpalate, toxoplasmosis, other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, congenital cardiac defect, neural tube defect, gastrointestinal tract anomalies, hydrocephalus, NEC\\]\n* Severe birth asphyxia\n* Critically ill (i.e. not on enteral feeds)\n* Unknown date of birth and unknown gestational age",true,"48 Hours",{"count":53,"type":21},776,[24],"The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in the NICU compared to not feeding routinely fortified human milk using the standardized clinical protocol.\n\nThe primary research question is: Will VLBW or VPT infants in the NICU who are fed fortified human milk using a standardized feeding protocol have better growth outcomes by facility discharge and at 3 months of age, less illness by discharge, and decreased mortality by discharge and at one month compared to those who are not routinely fed fortified human milk using the same feeding protocol?",[27,57],"Very Low Birthweight",[59,60,61,62],"very preterm","very low birthweight","fortification","human milk","RECRUITING","2026-01-16",{"date":66,"type":33},"2026-01-21",{"date":68,"type":33},"2025-01-16",{"date":70,"type":21},"2027-03-31",{"name":72,"class":40},"Harvard School of Public Health (HSPH)",4]