Early Total Enteral Feeding versus Conventional Enteral Feeding in stable very preterm infants 28+0 to 31+6 weeks of period of gestation A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postnatal age at attaining 150 mL/kg/day feed
研究概览
简要总结
In this study, 28+0 to 31+6 weeker haemodynamically stable babies admitted at inborn NICU will be included. According to total fluid requirements, trial group will be introduced full enteral feed since D1 of life and the control group will be introduced 20 mL/kg/day enteral feed; whereas rest of the requirement will be met in the form of intravenous fluid. As per tolerance of feed of babies, feed will be advanced and primary outcome will be assessed in terms of postnatal age when 150 mL/kg/ day feed is reached. The two groups will be compared by means of episodes of feed intolerance, incidence of sepsis and necrotizing enterocolitis as well as duration of hospital stay.
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
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Neonates of POG 28+0 to 31+6 weeks 2.Haemodynamically stable 3.Admitted in Inborn NICU.
排除标准
- •Babies with significant congenital anomalies
- •Less than 1 kg birth weight
- •Less than 28 weeks / more than 32 weeks POG
- •Babies with shock requiring inotropic support
- •APGAR score less than 5/10 at 10 min of life
- •significant hypoglycemia.
结局指标
主要结局
Postnatal age at attaining 150 mL/kg/day feed
时间窗: At the time of discharge from NICU
次要结局
- 1. Episodes of feed intolerance(2. Incidence of sepsis and necrotizing enterocolitis)
研究者
Dr Madhurima Karak
Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences, Kolkata