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临床试验/CTRI/2024/09/073562
CTRI/2024/09/073562招募中3 期

Comparison of effectiveness of phototherapy with and without Kangaroo mother care in preterm neonates with hyperbilirubinemia a randomized control trial

Uttar Pradesh University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2024年9月10日最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
148
试验地点
1
主要终点
Rate of fall of bilirubin in term neonates

研究概览

简要总结

This study is a randomized, single blind, parallel group, active controlled trial comparing the effectiveness of continuous phototherapy and phototherapy with Kangaroo mother care (2 hours Kangaroo mother care after each 6 hours of phototherapy) in Pre-term neonates with hyperbilirubinemia. The primary outcome measure will be rate of fall of bilirubin. Secondary outcome will be hospital stay and rebound of hyperbilirubinemia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
1.00 Day(s) 至 7.00 Day(s)(—)
性别
All

入选标准

  • Pre-term neonates whose bilirubin level is above the range of pathological hyperbilirubinemia as per American academy of pediatrics nomogram irrespective of cause of hyperbilirubinemia.

排除标准

  • 未提供

结局指标

主要结局

Rate of fall of bilirubin in term neonates

时间窗: After 12 hours, 24 hours, 36 hours and 48 hours

次要结局

  • Hospital stay & rebound hyperbilirubinemia(After 24 hours 36 hours & 48 hours)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Durgesh Kumar

Uttar Pradesh University of Medical Sciences, Saifai, Etawah

研究点 (1)

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