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