CTRI/2024/01/062080尚未招募1/2 期
Rapid versus slow advancement of feeds in early fed preterm iugr neonates 34 weeks:A randomised control trial
适应症
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Estimation of days to attain full feeds defined as 150ml/kg/day in preterm IUGR babies less than 34 weeks fed early where the feeds are rapidly progressed compared to where the feeds are advanced slowly.
研究概览
简要总结
There is limited evidence on feeding policy in preterm IUGR severe IUGR newborns. Studies done in preterm IUGR have adapted different definitions of early feeding. Even though recent studies have documented the advantage of early feeding but data with regard to the possibility and advantage of rapid progression in these newborns is negligible. BY this study we want to prove that early and rapid advancement of feeding in this population is beneficial.
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
- 7.00 Month(s) 至 8.00 Month(s)（—）
- 性别
- All
入选标准
- •All preterm IUGR neonates less than 34 weeks with birth weight below the 3rd centile on the Intergrowth 21 charts for the gestational age, admitted to the Neonatal Intensive Care Unit.
排除标准
- •Exclusion Criteria: The following neonates will be excluded: •Antenatally suspected intestinal anomaly •Lethal congenital anomaly •Dysmorphic or Syndromic baby •Neonates needing invasive ventilation •Inotropic support and on more than 1 ionotrope with instability •History of extensive resuscitation with apgar at 5 min <5 •All babies with surgical conditions.
- •â€¢Twins with evidence of Twin-Twin transfusion.
- •â€¢Intrauterine transfusion or exchange transfusion.
- •â€¢Any evidence of hydrops.
结局指标
主要结局
Estimation of days to attain full feeds defined as 150ml/kg/day in preterm IUGR babies less than 34 weeks fed early where the feeds are rapidly progressed compared to where the feeds are advanced slowly.
时间窗: time to achieve full feeds in rapid group at 6 days vs slow group at 10 days
次要结局
- The following will be the secondary objectives investigated in the study, wherein the difference in the rapidly progressing group & the slow advancement of feeds will be estimated.(Incidence of shock during feeding needing any ionotropic support)
研究者
研究点 (1)
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