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临床试验/CTRI/2026/01/102411
CTRI/2026/01/102411尚未招募不适用

Comparison of Head vs Head & Neck covering in preventing Phototherapy induced Hypocalcemia in Neonates - A Randomized Controlled Trial

Dr Mohamed Suhail M1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年2月11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

研究概览

简要总结

Neonatal hyperbilirubinemia affects a majority of newborns and often requires phototherapy. A common complication is phototherapy induced hypocalcemia, potentially caused by light induced suppression of melatonin secretion by pineal gland. While studies suggest head covering reduces this risk, evidence is limited regarding whether extending coverage to the neck provides additional protection.

This randomized controlled trial involving 100 neonates (less than or equal to 7 days old) aims to compare the effectiveness of head only covering versus combined head and neck covering in preventing Hypocalcemia. Participants will be randomized into two groups, Total serum calcium will be measured at baseline and after 24 hours of phototherapy. The study also evaluates neonatal comfort and the severity of any observed hypocalcemia. This simple, low cost intervention aims to optimize neonatal safety during phototherapy, particularly in resource limited settings.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • All clinical neonatal jaundice babies receiving phototherapy who are less than or equal to Seven days old at the time of initiation of phototherapy.

排除标准

  • Neonates with sepsis, Existing hypocalcemia, those on calcium supplementation, or any other illness requiring NICU admission and refusal/withdrawal of informed parental consent.

研究者

发起方
Dr Mohamed Suhail M
申办方类型
Other [Postgraduate student]
责任方
Principal Investigator
主要研究者

Dr Mohamed Suhail M

Vinayaka Mission’s Medical College

研究点 (1)

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