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临床试验/CTRI/2017/11/010577
CTRI/2017/11/010577已完成不适用

A randomised control trial to compare growth velocity in VLBW neonates (1-1.5 kg) fed at 2 hourly and 3 hourly intervals

Christian Medical College1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年11月30日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
1
主要终点
To compare weight gain velocity (gm/kg/day) in VLBW babies receiving 2 hourly v/s 3 hourly feeds

研究概览

简要总结

Adequate nutrition plays an important role in survival, growth and development of preterm infants. Nutrition in preterm infants can be given via enteral or parenteral route. Parenteral route has complications of vascular catheterisation, sepsis, fasting and adverse effects of nutrition. The cost is also increased with use of TPN. Enteral feeding is also beneficial as it improves gastro-intestinal motility, increases release of gastro-intestinal hormones which have trophic effects and leads to decreased feed intolerance. Enteral feeding practices vary between different neonatal units. Preterm neonates have lack of co-ordination between sucking, swallowing and breathing hence gavage feeding is started. They are arbitrarily given bolus feeding at fixed intervals or given continuous feeds. Bolus feeding may be more physiological as it brings about more natural surges in intestinal hormones. Bolus feeding is also given at different intervals(1 hourly, 2 hourly, 3 hourly). There is no consensus on what feed interval to be followed in preterm VLBW infants. In our nursery, 2 hours feeding regimen is routinely followed with few babies being shifted to 1 hourly, 3 hourly or continuous feeds as per clinician’s decision. This study is designed to evaluate the weight gain velocity of babies receiving 3 hourly feeds as compared to 2 hourly feeds.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Not Applicable

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • To compare weight gain velocity (gm/kg/day) in VLBW babies receiving 2 hourly v/s 3 hourly feeds.

排除标准

  • Infants with major congenital anomalies, surgical conditions, conditions where feed intolerance is anticipated.
  • Lack of Consent 3) Clinician decision regarding poor chances of survival.

结局指标

主要结局

To compare weight gain velocity (gm/kg/day) in VLBW babies receiving 2 hourly v/s 3 hourly feeds

时间窗: weight of baby 1.8kg

次要结局

  • 1) Time to reach birth weight(2) Time to reach full feeds (200 ml/kg/day))

研究者

申办方类型
Private medical college

研究点 (1)

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