Bovine derived versus plant based human milk fortification in preterm infants of less than 30 weeks gestation An open labelled multi-center randomized controlled trail
试验速览
- 阶段
- 不适用
- 状态
- Other (Terminated)
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- time to reach enteral feed volume of 180ml per kg per day, rate of weight gain, head circumference increment and length increment
研究概览
简要总结
This study will be conducted in level III NICU, from August 2024 to October 2025 in neonates born <30 weeks of gestation, meeting the inclusion criteria. After obtaining consent, the neonate will be assigned into group either fortification of EBM with bovine or plant based HMF after randomization. Baseline information and anthropometric measurements will be recorded at enrolment and every week. Fortification will be continued till the neonate reaches 2 kg or reaches 40 weeks PMA, whichever is earlier. The time taken to reach 180ml/kg feeds, incidence of NEC and death will be recorded until fortification is done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •preterm neonates who are started on mothers own milk or pasteurised donor human milk within 48hours of life and total parenteral nutrition within 6 hours of life.
排除标准
- •preterm neonates with gross congenital anomalies
- •preterm neonates whose caretakers refuse to give consent.
结局指标
主要结局
time to reach enteral feed volume of 180ml per kg per day, rate of weight gain, head circumference increment and length increment
时间窗: at discharge and at 40weeks PMA.
次要结局
- Incidence of feed intolerance defined as necessity to keep the neonate nil by mouth for at least 1 day(NEC stage more than or equal to 2 Modified Bells’ staging)
研究者
Nikhil Kumar M
Ankura hospital for women and children