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临床试验/NCT01367015
NCT01367015已完成不适用

A Randomized Clinical Trial on Comparison of Early Versus Late Initiation of Feeding in Preterm Small for Gestation Infants Below 35 Weeks Gestation With Prenatal Absent or Reversal of End Diastolic Flow (AREDF) in Umbilical Artery

All India Institute of Medical Sciences, New Delhi2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Days to achieve full feeds defined as 150mL/kg

研究概览

简要总结

The purpose of the study is to compare early versus late initiation of enteral feeding in premature growth restricted babies below the gestational age of 35 weeks born to mothers with prenatal absent or reversal of end diastolic flow in the umbilical artery. Normally the blood flow from the mother to the baby brings all the nutrients required for growth and the very vital oxygen required for survival. These deprived babies with poor blood flow adapt to the not so conducive uterine environment by certain adjustments in blood supply to internal organs. This permits the best possible blood flow to brain heart etc., which are the vital organs and whose adequate functioning is required for survival. As a consequence, the gut (intestines) gets poor blood supply and hence its appropriate functioning may be jeopardized. Such 'premature growth restricted' babies are at increased risk of further growth faltering if not fed adequately as also to a condition called 'Necrotising enterocolitis' if fed liberally like other healthy neonates, characterized by abdominal distension, blood in stools and inability to feed for longer durations thereby further affecting growth. In the past such babies (after birth) were not fed for days together which compromised their growth even further. It is not clear whether continuing to withhold feeds for prolonged duration will prevent NEC but lead to growth faltering and initiating feeds early will potentiate NEC with further compromised growth and increased morbidity. There are no randomized trials on feeding strategies in this group of neonates and hence the investigators planned to carry out this study on comparison of early versus delayed initiation of feeding in preterm SGA infants with AREDF.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
48 Hours 至 72 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm neonates below 35 weeks gestation born at the study center(s)
  • Small for gestational age (SGA) ie weight < 10th centile for gestation
  • Absent or reverse end diastolic flow (AREDF) in umbilical artery

排除标准

  • Babies with major congenital malformations.
  • Babies with severe asphyxia as defined by apgar score <4 at 5 min of life with cord/within one hour of life pH< 7.
  • Shock requiring pressor support at the time of randomization.
  • Babies born with gastrointestinal surgical conditions precluding enteral feeding.
  • Babies with abdominal distension, bilious or hemorrhagic aspirates or recurrent vomiting at the time of randomization.
  • Refusal to obtain consent.
  • Gestation below 26 weeks.
  • Hydrops fetalis.

结局指标

主要结局

Days to achieve full feeds defined as 150mL/kg

时间窗: upto 12 weeks (84 days)

First day of the three days when full enteral feeding of 150 ml/kg has been achieved and sustained as recorded from the nursing chart of the neonate

次要结局

  • Days to regain birth weight(upto 16 weeks (112 days))
  • Feed intolerance(12 weeks (84 days))
  • Duration of stay(12 - 16 weeks (84 - 112 days))

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Other

研究点 (2)

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