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The Effects of Different Enteral Feeding Regimens on Necrotizing Enterocolitis, Mortality, and Neurodevelopment in Very Preterm Infants: A Multicenter Double-Randomized Trial
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: Does 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? Researchers will compare: pHDM 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. Participants will: Be randomized twice: * First, within the first week of life to receive either pHDM or PTF when OMM is insufficient * 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. COLLABORATE-China is being run in partnership with the UK-wide COLLABORATE trial sponsored by Imperial College London.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
The First Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Yulin Maternity and Child Health Care Hospital, Guangxi
Yulin, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guizhou, Guiyang, China
Nanyang Central Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Yiyang Central Hospital
Yiyang, Hunan, China
Ganzhou Maternal and Child Health Hospital
Ganzhou, Jiangxi, China
Peking University First Hospital Ningxia Women and Children's Hospital (Ningxia Hui Autonomous Region Maternal and Child Health Hospital)
Yinchuan, Ningxia, China
Shandong Provincial Maternal and Child Health Care Hospital
Jinan, Shandong, China
Start Date
March 2, 2026
Primary Completion Date
July 31, 2028
Completion Date
July 31, 2030
Last Updated
February 24, 2026
2,324
ESTIMATED participants
Pasteurized Donor Milk for Insufficient Breastfeeding
DIETARY_SUPPLEMENT
Preterm Formula for Insufficient Breastfeeding
DIETARY_SUPPLEMENT
Routine fortification
DIETARY_SUPPLEMENT
Rescue fortification
DIETARY_SUPPLEMENT
Lead Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Collaborators
NCT00747851
NCT06727877
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06870318