[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596467":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":39,"locations":45,"responsibleParty":376,"collaborators":378,"id":381,"slug":382,"hasResults":383,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":26,"eligibilityCriteria":387,"healthyVolunteers":383,"sex":388,"minAge":389,"maxAge":390,"enrollmentInfo":391,"targetDuration":26,"studyType":394,"phases":395,"briefSummary":397,"conditions":398,"keywords":26,"overallStatus":401,"whyStopped":26,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":411},{"fullName":5,"class":6},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Pasteurized Donor Milk for Insufficient Breastfeeding","EXPERIMENTAL","Participants receive pasteurized donor human milk (pHDM) as supplemental feeding when the clinician determines maternal milk supply is insufficient.",[13,14,15],"Dietary Supplement: Pasteurized Donor Milk for Insufficient Breastfeeding","Dietary Supplement: Routine fortification","Dietary Supplement: Rescue fortification",{"label":17,"type":10,"description":18,"interventionNames":19},"Preterm formula for Insufficient Breastfeeding","Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient.",[20,14,15],"Dietary Supplement: Preterm Formula for Insufficient Breastfeeding",[22,27,31,35],{"type":23,"name":9,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Participants receive pasteurized donor human milk (pHDM) as supplemental feeding when the clinician determines maternal milk supply is insufficient.\n\nRandomization 1 will occur when the clinician determines that supplemental feeding is required due to insufficient breast milk supply.",[9],null,{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Preterm Formula for Insufficient Breastfeeding","Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient.\n\nRandomization 1 will occur when the clinician determines that supplemental feeding is required due to insufficient breast milk supply.",[17],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Routine fortification","Randomization 2 will be conducted when the total daily intake of human milk (including own mother's milk \\[OMM\\] and\u002For donor pasteurized human milk \\[pHDM\\] ) reaches between 60-120 mL\u002Fkg",[9,17],{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":26},"Rescue fortification","Randomization 2 will be conducted: Add fortifiers when the infant meets predefined criteria for growth faltering (Preterm infants exhibit a sustained decline in growth velocity for weight, length, or head circumference, demonstrated by a downward crossing of centiles on growth curves, despite tolerating and consuming at least 180 mL\u002Fkg\u002Fday of breast milk or formula. Blood urea levels in these infants remain consistently below 1.5 mmol\u002FL, and there are no severe complications such as active sepsis or the need for vasoactive medications to maintain circulatory stability. Chronic sodium depletion has also been ruled out, as this condition alone can lead to growth failure. Additionally, preterm infants are unable to tolerate high-volume feeding of 180 mL\u002Fkg\u002Fday due to specific reasons, such as severe gastroesophageal reflux or the presence of a high-output stoma following surgical procedures).",[9,17],[40],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Yanping Xu","CONTACT","8613685757726","xuyanping726@zju.edu.cn",[46,67,81,95,110,125,138,152,166,180,194,209,222,236,252,274,288,300,314,326,343,359],{"facility":47,"status":26,"city":48,"state":49,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"The First Affiliated Hospital of Guilin Medical University","Guilin","Guangxi","China","CN",{"type":53,"coordinates":54},"Point",[55,56],110.29639,25.28022,{"lat":56,"lon":55},[59,62,64],{"name":60,"role":42,"phone":61,"phoneExt":26,"email":26},"Yuan Tan","13707837294",{"name":60,"role":63,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":65,"role":66,"phone":26,"phoneExt":26,"email":26},"Yongjie Liao","SUB_INVESTIGATOR",{"facility":68,"status":26,"city":69,"state":49,"zip":70,"country":50,"countryCode":51,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"The Second Affiliated Hospital of Guangxi Medical University","Nanning","530007",{"type":53,"coordinates":72},[73,74],108.31667,22.81667,{"lat":74,"lon":73},[77,80],{"name":78,"role":42,"phone":79,"phoneExt":26,"email":26},"Qiaozhen Wei","15994596410",{"name":78,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":82,"status":26,"city":83,"state":49,"zip":84,"country":50,"countryCode":51,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Yulin Maternity and Child Health Care Hospital, Guangxi","Yulin","537000",{"type":53,"coordinates":86},[87,88],110.14686,22.6305,{"lat":88,"lon":87},[91,94],{"name":92,"role":42,"phone":93,"phoneExt":26,"email":26},"Yaoxun Wu","13768963338",{"name":92,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":96,"status":26,"city":97,"state":98,"zip":99,"country":50,"countryCode":51,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"The Affiliated Hospital of Guizhou Medical University","Guizhou","Guiyang","550001",{"type":53,"coordinates":101},[102,103],110.58333,31.01667,{"lat":103,"lon":102},[106,109],{"name":107,"role":42,"phone":108,"phoneExt":26,"email":26},"Shilan Xiao","18984355441",{"name":107,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":111,"status":26,"city":112,"state":113,"zip":114,"country":50,"countryCode":51,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Nanyang Central Hospital","Nanyang","Henan","473000",{"type":53,"coordinates":116},[117,118],112.54659,33.00524,{"lat":118,"lon":117},[121,124],{"name":122,"role":42,"phone":123,"phoneExt":26,"email":26},"Ping Zhu","13569272770",{"name":122,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":126,"status":26,"city":127,"state":113,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"The First Affiliated Hospital of Zhengzhou University","Zhengzhou",{"type":53,"coordinates":129},[130,131],113.64861,34.75778,{"lat":131,"lon":130},[134,137],{"name":135,"role":42,"phone":136,"phoneExt":26,"email":26},"Qianya Xu","13203805371",{"name":135,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":139,"status":26,"city":140,"state":141,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Yiyang Central Hospital","Yiyang","Hunan",{"type":53,"coordinates":143},[144,145],112.37925,26.38893,{"lat":145,"lon":144},[148,151],{"name":149,"role":42,"phone":150,"phoneExt":26,"email":26},"Xianglian Liu","15898439990",{"name":149,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":153,"status":26,"city":154,"state":155,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Ganzhou Maternal and Child Health Hospital","Ganzhou","Jiangxi",{"type":53,"coordinates":157},[158,159],114.9326,25.84664,{"lat":159,"lon":158},[162,165],{"name":163,"role":42,"phone":164,"phoneExt":26,"email":26},"Xiaohua Luo","18079708860",{"name":163,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":167,"status":26,"city":168,"state":169,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Peking University First Hospital Ningxia Women and Children's Hospital (Ningxia Hui Autonomous Region Maternal and Child Health Hospital)","Yinchuan","Ningxia",{"type":53,"coordinates":171},[172,173],106.27306,38.46806,{"lat":173,"lon":172},[176,179],{"name":177,"role":42,"phone":178,"phoneExt":26,"email":26},"Yuhua Wu","17709589568",{"name":177,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":181,"status":26,"city":182,"state":183,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"Shandong Provincial Maternal and Child Health Care Hospital","Jinan","Shandong",{"type":53,"coordinates":185},[186,187],116.99722,36.66833,{"lat":187,"lon":186},[190,193],{"name":191,"role":42,"phone":192,"phoneExt":26,"email":26},"Zhengxia Wan","15153167517",{"name":191,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":195,"status":26,"city":196,"state":197,"zip":198,"country":50,"countryCode":51,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Sichuan Provincial Maternal and Child Health Hospital","Chengdu","Sichuan","610045",{"type":53,"coordinates":200},[201,202],104.06667,30.66667,{"lat":202,"lon":201},[205,208],{"name":206,"role":42,"phone":207,"phoneExt":26,"email":26},"Jingmei Hao","18280350267",{"name":206,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":210,"status":26,"city":211,"state":197,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"The Affiliated Hospital of Southwest Medical University","Luzhou",{"type":53,"coordinates":213},[214,215],105.42575,28.8903,{"lat":215,"lon":214},[218,221],{"name":219,"role":42,"phone":220,"phoneExt":26,"email":26},"Lan Kang","13982762269",{"name":219,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":223,"status":26,"city":224,"state":225,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"People's Hospital of Xinjiang Uygur Autonomous Region","Ürümqi","Xinjiang Uygur Autonomous Region",{"type":53,"coordinates":227},[228,229],87.60046,43.80096,{"lat":229,"lon":228},[232,235],{"name":233,"role":42,"phone":234,"phoneExt":26,"email":26},"Jinfeng He","13565924349",{"name":233,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":237,"status":26,"city":238,"state":239,"zip":240,"country":50,"countryCode":51,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"Yongkang Maternity and Child Health Care Hospital","Guli","Zhejiang","321300",{"type":53,"coordinates":242},[243,244],120.03308,28.88162,{"lat":244,"lon":243},[247,251],{"name":248,"role":42,"phone":249,"phoneExt":26,"email":250},"Aijuan Yang","8613506790182","55724110@qq.com",{"name":248,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":253,"status":26,"city":254,"state":239,"zip":255,"country":50,"countryCode":51,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"Children's Hospital, Zhejiang University School of Medicine","Hangzhou","0571",{"type":53,"coordinates":257},[258,259],120.16142,30.29365,{"lat":259,"lon":258},[262,266,267,268,270,272],{"name":263,"role":42,"phone":264,"phoneExt":26,"email":265},"Zheng Chen","0571-13857151000","chenz@zju.edu.cn",{"name":263,"role":63,"phone":26,"phoneExt":26,"email":26},{"name":41,"role":63,"phone":26,"phoneExt":26,"email":26},{"name":269,"role":63,"phone":26,"phoneExt":26,"email":26},"Daqing Ma",{"name":271,"role":63,"phone":26,"phoneExt":26,"email":26},"Lizhong Du",{"name":273,"role":66,"phone":26,"phoneExt":26,"email":26},"Mingyan Chen",{"facility":275,"status":26,"city":254,"state":239,"zip":276,"country":50,"countryCode":51,"cosmosGeoPoint":277,"geoPoint":279,"contacts":280},"The First Affiliated Hospital, Zhejiang University School of Medicine","310003",{"type":53,"coordinates":278},[258,259],{"lat":259,"lon":258},[281,285,286],{"name":282,"role":42,"phone":283,"phoneExt":26,"email":284},"Fang Luo","8613616542920","csuanna@163.com",{"name":282,"role":63,"phone":26,"phoneExt":26,"email":26},{"name":287,"role":66,"phone":26,"phoneExt":26,"email":26},"Xiaofei Luo",{"facility":289,"status":26,"city":254,"state":239,"zip":290,"country":50,"countryCode":51,"cosmosGeoPoint":291,"geoPoint":293,"contacts":294},"Women's Hospital, Zhejiang University School of Medicine","310006",{"type":53,"coordinates":292},[258,259],{"lat":259,"lon":258},[295,299],{"name":296,"role":42,"phone":297,"phoneExt":26,"email":298},"Jiajun Zhu","8613858089111","jiajunzhu@zju.edu.cn",{"name":296,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":301,"status":26,"city":254,"state":239,"zip":302,"country":50,"countryCode":51,"cosmosGeoPoint":303,"geoPoint":305,"contacts":306},"Hangzhou Women's Hospital","310008",{"type":53,"coordinates":304},[258,259],{"lat":259,"lon":258},[307,311,312],{"name":308,"role":42,"phone":309,"phoneExt":26,"email":310},"Weinong Mo","8613606719109","hzxsmwn@126.com",{"name":308,"role":63,"phone":26,"phoneExt":26,"email":26},{"name":313,"role":66,"phone":26,"phoneExt":26,"email":26},"jing Li",{"facility":315,"status":26,"city":254,"state":239,"zip":316,"country":50,"countryCode":51,"cosmosGeoPoint":317,"geoPoint":319,"contacts":320},"Sir Run Run Shaw Hospital, Zhejiang University School of Medicine","310016",{"type":53,"coordinates":318},[258,259],{"lat":259,"lon":258},[321,325],{"name":322,"role":42,"phone":323,"phoneExt":26,"email":324},"Zhou Jiang","8613588878072","5200013@zju.edu.cn",{"name":322,"role":63,"phone":26,"phoneExt":26,"email":26},{"facility":327,"status":26,"city":328,"state":239,"zip":329,"country":50,"countryCode":51,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"Jiaxing Maternity and Child Health Care Hospital","Jiaxing","314000",{"type":53,"coordinates":331},[332,333],120.75,30.7522,{"lat":333,"lon":332},[336,340,341],{"name":337,"role":42,"phone":338,"phoneExt":26,"email":339},"Huafei Huang","8613867344127","39362000@qq.com",{"name":337,"role":63,"phone":26,"phoneExt":26,"email":26},{"name":342,"role":66,"phone":26,"phoneExt":26,"email":26},"Minjia Zhou",{"facility":344,"status":26,"city":345,"state":239,"zip":346,"country":50,"countryCode":51,"cosmosGeoPoint":347,"geoPoint":351,"contacts":352},"Ningbo Women and Children's Hospital (The Affiliated Women and Children's Hospital of Ningbo University)","Ningbo","315012",{"type":53,"coordinates":348},[349,350],121.54945,29.87819,{"lat":350,"lon":349},[353,357],{"name":354,"role":42,"phone":355,"phoneExt":26,"email":356},"Qin Lv","8613738822179","artose@sina.com",{"name":358,"role":63,"phone":26,"phoneExt":26,"email":26},"Yanhong Li",{"facility":360,"status":26,"city":361,"state":239,"zip":362,"country":50,"countryCode":51,"cosmosGeoPoint":363,"geoPoint":367,"contacts":368},"Yiwu Maternity and Child Health Care Hospital (Yiwu Branch of The Children's Hospital, Zhejiang University School of Medicine)","Yiwu","322000",{"type":53,"coordinates":364},[365,366],120.07676,29.31506,{"lat":366,"lon":365},[369,373,374],{"name":370,"role":42,"phone":371,"phoneExt":26,"email":372},"Shujun Chen","8618314930492","12444229204@qq.com",{"name":370,"role":63,"phone":26,"phoneExt":26,"email":26},{"name":375,"role":66,"phone":26,"phoneExt":26,"email":26},"Cuie Chen",{"type":63,"investigatorFullName":41,"investigatorTitle":377,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Dr.",[379],{"name":380,"class":6},"Imperial College London","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":392,"type":393},2324,"ESTIMATED","INTERVENTIONAL",[396],"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.",[399,400],"Very Preterm Infant","Necrotizing Enterocolitis (NEC)","NOT_YET_RECRUITING","2026-02-22",{"date":404,"type":405},"2026-02-24","ACTUAL",{"date":407,"type":393},"2026-03-02",{"date":409,"type":393},"2030-07-31",{"name":5,"class":6},22]