1,013
Participants
Start Date
August 1, 2025
Primary Completion Date
July 31, 2028
Study Completion Date
July 31, 2030
Pasteurized Donor Milk for Insufficient Breastfeeding
"Participants receive pasteurized donor human milk (pHDM) as supplemental feeding when the clinician determines maternal milk supply is insufficient.~Randomization 1 will occur when the clinician determines that supplemental feeding is required due to insufficient breast milk supply."
Preterm Formula for Insufficient Breastfeeding
"Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient.~Randomization 1 will occur when the clinician determines that supplemental feeding is required due to insufficient breast milk supply."
Routine fortification
Randomization 2 will be conducted when the total daily intake of human milk (including own mother's milk \[OMM\] and/or donor pasteurized human milk \[pHDM\] ) reaches between 60-120 mL/kg
Rescue fortification
Randomization 2 will be conducted: Add fortifiers when the body weight is below the 10% growth curve.
Children's Hospital, Zhejiang University School of Medicine, Hangzhou
Chengdu Maternal and Children's Health Care Hospital, Chengdu
Children's Hospital of Chongqing Medical University, Chongqing
Guangdong Women and Children Hospital, Guangdong
Guangxi Maternal and Child Health Hospital, Guangxi
Guiyang Maternity and Child Health Care Hospital, Guiyang
Guizhou Provincial People's Hospital, Guizhou
The First Hospital of Jilin University, Jilin
First Affiliated Hospital of Kunming Medical University, Kunming
Jiangxi Maternal and Child Health Hospital, Nanchang
Nanjing Maternity and Child Health Care Hospital, Nanjing
Ningbo Women & Children's Hospital, Ningbo
QuanZhou Women and Children's Hospital, Quanzhou
Qujing Maternal and Child Health Hospital, Qujing
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai
Shengjing Hospital, Shenyang
Shenzhen Maternal and Child Health Hospital, Shenzhen
Fourth Hospital of Shijiazhuang City, Shijiazhuang
Xiamen Women's and Children's Hospital, Xiamen
First Affiliated Hospital of Xinjiang Medical University, Xinjiang
Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou
Zhengzhou Children's Hospital, China, Zhengzhou
Imperial College London
OTHER
The Children's Hospital of Zhejiang University School of Medicine
OTHER