A randomized controlled trial to compare the efficacy of expressed breast milk, facilitated tucking and combination of expressed breast milk and facilitated tucking in providing pain relief after heel-stick in preterm infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- To compare the efficacy of expressed breast milk, facilitated tucking & combination of expressed breast milk & facilitated tucking in providing pain relief after heel-stick in preterm infants at the time of heel-stick using PIPP score (Premature Infant Pain Profile score) and compare the score before and after the heel-stick
研究概览
简要总结
Our study aims to compare the efficacy ofexpressed breast milk and facilitated tucking in relieving preterm infants’pain in heel-stick procedure.So far no study has been done in India to compare the effects of expressedbreast milk with facilitated tucking either alone or in combination for preterminfants’ pain relief during heel-sticking. Although, it has been suggested that24% sucrose solution acts as an effective pain management strategy for preterminfants before heel-stick procedure, it is not availablein the Indian market. Our alternative,that is, expressed breast milk and facilitated tucking are inexpensive, quick,easy to use and accessible in every settings, and therefore can be used as painrelieving methods of treatment before heel-sticking. Also,the findings will help to provide the best method to relief newborn pain after heel-stick procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 0.00 Day(s) 至 2.00 Day(s)（—）
- 性别
- All
入选标准
- •All newborns from 27 to less than 37 weeks.
排除标准
- •preterm infants on invasive ventilation 2) major congenital malformation or known genetic abnormalities 3) preterm infants with encephalopathy 4)Preterm infants receiving sedatives 5) hemodynamically unstable preterm infants.
结局指标
主要结局
To compare the efficacy of expressed breast milk, facilitated tucking & combination of expressed breast milk & facilitated tucking in providing pain relief after heel-stick in preterm infants at the time of heel-stick using PIPP score (Premature Infant Pain Profile score) and compare the score before and after the heel-stick
时间窗: at time of heel-stick
次要结局
- To compare the efficacy of expressed breast milk, facilitated tucking & combination of expressed breast milk & facilitated tucking in providing pain relief after heel-stick in preterm infants at 1 & 4 minutes using PIPP score (Premature Infant Pain Profile score)(1 minute & 4 minutes)