跳至主要内容
临床试验/CTRI/2018/05/014006
CTRI/2018/05/014006尚未招募不适用

Randomized controlled double masked crossover trial comparing Kangaroo Mother Care and Sucrose in Reducing Pain in Preterm Neonates on Heel Prick

Charutar Arogya Mandal1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年5月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Premature infant pain profile(pipp)score at end of procedure.

研究概览

简要总结

.International Association for the Study of Pain defines pain as an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. Sucrose has been shown to be effective. Breast feeding is effective, but has only been reported to be used for pain control in full-term neonates. Premature infants are not being breast fed during the days when most invasive procedures are carried out as they may not have the developmental maturity. It is proposed that it may be the contact of breast feeding, and not the breast milk per se, which is efficacious in decreasing pain . Thus for the preterm group, KMC would be a cost effective analgesic and provide mothers a greater sense of responsibility for their sick babies. Studies have compared the effect of KMC and oral sucrose on pain response in neonates and show that KMC acts synergistically with other nonpharmacological modalities in reducing pain . Multiple studies have shown the benefits of Kangaroo mother care and oral Sucroseon neonatal pain reduction.

Neonates born prematurely who spend the initial weeks of their lives in NICUs, undergo many invasive procedures (an average of 2–3/d, up to 8–10 /d) without benefit of analgesia of which heel pricking is one of the most common procedure.pain associated with routine procedures in preterm neonates is associated with abnormal neurodevelopment,the effects of which may be persistent so it is of extreme importance to treat and reduce pain, especially premature neonates during their stay within the NICU.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • 28-36 weeks gestation neonates.

排除标准

  • 1.Neonates on ventilator
  • Clinically evident abnormal neurological signs
  • Have received analgesics/sedatives within last 24 h.

结局指标

主要结局

Premature infant pain profile(pipp)score at end of procedure.

时间窗: Measured at various intervals during painful procedure. | 0,30,60 at 30 second intervals till completion of procedure.

次要结局

未报告次要终点

研究者

发起方
Charutar Arogya Mandal
申办方类型
Research institution and hospital

研究点 (1)

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