Early Versus Late Feeding in Preterm neonates with Absent or Reversed End Diastolic Flow on Antenatal Umbilical Doppler studyâ€: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time taken to achieve full enteral feeds
研究概览
简要总结
This study is being conducted in preterm babies born with antenatal abnormal dopplers . After randomization these babies will be divided into two groups , early and late feeding groups and will be fed according to the protocol till they reach a full feeds of 150 ml per kg per day. during their hospital stay , babies will be monitored for signs of feed intolerance and action will be taken accordingly.Time taken to reach full feed will be taken as primary outcome . And ,incidence of NEC, day of regaining birthweight, duration of Parenteral nutrition, duration of hospitalization and incidence of late onset sepsis will be the secondary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 2.00 Day(s)(—)
- 性别
- All
入选标准
- •Preterm babies with abnormal dopplers will be randomized within 6 hours of life.
排除标准
- •1.Neonates with major congenital malformations including gastrointestinal obstruction 2.Babies with known chromosomal abnormality or with dysmorphic features 3.Neonates with severe birth asphyxia (APGAR <4 at 5 min of life with cord/within 1 hour of life pH <7) 4.Twin to twin transfusion 5.Neonates requiring intrauterine transfusion or exchange transfusion 6.Significant multi-organ failure prior to trial entry 7.Inotropic support prior to trial entry 8.Already received any enteral feeding.
结局指标
主要结局
Time taken to achieve full enteral feeds
时间窗: till the hospital stay
次要结局
- 1.Incidence of NEC(2.Day of regaining birthweight)
