The Effects of Different Enteral Feeding Regimens on Necrotizing Enterocolitis, Mortality, and Neurodevelopment in Very Preterm Infants: A Multicenter Double-Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,324
- 试验地点
- 23
- 主要终点
- Survival without surgical NEC
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age at birth less than 29 weeks;
- •No contraindications to enteral feeding;
- •Mother is willing to breastfeed.
排除标准
- •For Randomization Group 1: If the infant has already received pasteurized human donor milk (pHDM), preterm formula (PTF), or nutritional fortifiers;
- •For Randomization Group 2: If the infant is exclusively fed with preterm formula and the mother has no intention to express breast milk;
研究组 & 干预措施
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.
干预措施: Pasteurized Donor Milk for Insufficient Breastfeeding (Dietary Supplement)
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.
干预措施: Routine fortification (Dietary Supplement)
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.
干预措施: Rescue fortification (Dietary Supplement)
Preterm formula for Insufficient Breastfeeding
Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
干预措施: Preterm Formula for Insufficient Breastfeeding (Dietary Supplement)
Preterm formula for Insufficient Breastfeeding
Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
干预措施: Routine fortification (Dietary Supplement)
Preterm formula for Insufficient Breastfeeding
Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
干预措施: Rescue fortification (Dietary Supplement)
结局指标
主要结局
Survival without surgical NEC
时间窗: 34 weeks corrected gestational age
Survival to 34 weeks corrected gestational age without surgical necrotizing enterocolitis (NEC)
次要结局
- NEC requiring surgical intervention(34 weeks gestational age)
- Survival(28 days after birth)
- Survival that occurred during hospitalization(From birth until hospital discharge (up to approximately 44 weeks postmenstrual age))
- Medically treated NEC that occurred during hospitalization(From birth until hospital discharge (up to approximately 44 weeks postmenstrual age))
- Treated retinopathy of prematurity (ROP) that occurred during hospitalization(From birth until hospital discharge (up to approximately 44 weeks postmenstrual age))
- Hearing impairment that occurred during hospitalization(From birth until hospital discharge (up to approximately 44 weeks postmenstrual age))
- Severe brain injury that occurred during hospitalization(From birth until hospital discharge (up to approximately 44 weeks postmenstrual age))
- Length of hospital stay(From birth until hospital discharge (up to approximately 44 weeks postmenstrual age))
- Number of episodes of bloodstream infection that occurred during hospitalization(From birth until hospital discharge (up to approximately 44 weeks postmenstrual age))
- Events that occurred during hospitalization(From birth until hospital discharge (up to approximately 44 weeks postmenstrual age))
- Number of days on parenteral nutrition that occurred during hospitalization(From birth until hospital discharge (up to approximately 44 weeks postmenstrual age))
- Number of days of NPO that occurred during hospitalization(From birth until hospital discharge (up to approximately 44 weeks postmenstrual age))
- Body weight(From birth until 2 years corrected age.)
- Body length(From birth until 2 years corrected age.)
- Head circumference(From birth until 2 years corrected age.)
- Parent Report of Children's Abilities-Revised (PARCA-R) assessment(At 2 years corrected age)
研究者
Yanping Xu
Dr.
The Children's Hospital of Zhejiang University School of Medicine