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临床试验/CTRI/2025/10/096260
CTRI/2025/10/096260尚未招募不适用

Baby Warmer Cloths With Adaptive Thermoregulation Property to Prevent Both Hypothermia and Hyperthermia in Twin Sharing Cot Versus Conventional Twin Sharing in Radiant Warmer: A Randomized Controlled Trial

DR ARPAN SAHA1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2025年11月1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
130
试验地点
1
主要终点
Primary outcome is number of incidence or episode of neonatal hypothermia or hyperthermia.

研究概览

简要总结

Maintaining thermal stability is vital for neonatal survival, particularly among preterm and low birth-weight infants who are prone to both hypothermia and hyperthermia due to immature thermoregulation. In resource-limited sick newborn care units (SNCUs), it is common for twin neonates to share a radiant warmer because of equipment constraints. However, conventional radiant warmers often provide uneven and non-individualized heat distribution, resulting in temperature fluctuations and increased risk of thermal imbalance.

This randomized controlled trial aims to evaluate the effectiveness of baby warmer cloths with adaptive thermoregulation properties compared to conventional radiant warmer-based twin sharing in preventing thermal dysregulation. The study will be conducted in the SNCU of a tertiary care teaching hospital over one year. Twin neonates with gestational age between 32 to 37 weeks and birth weight more than 1200 grams will be randomized into two groups: the intervention group, where adaptive thermoregulating cloths (using phase change materials) will be applied separately for each baby  in a twin-sharing cot, and the control group will receive  standard radiant warmer care only.

The primary outcome is the incidence of hypothermia (less than 36.5 degree celcius) and hyperthermia (more than 37.5 degree celcius) during the first 72 hours of life. Secondary outcomes include mean temperature trends, changes in daily weight, percentage of heater output of radiant warmer ( overall energy consumption), care giver satisfection and occurrence of adverse thermal events such as dehydration, incidence of sepsis in each group. Data will be analyzed using appropriate statistical tests (SPSS 25)

It is expected that neonates in the adaptive cloth group will experience fewer episodes of thermal instability, improved comfort, and reduced dependence on mechanical warming devices. The findings could support the integration of adaptive thermoregulating baby warmer cloths as a safe, sustainable, and cost-effective solution for neonatal thermal management, especially in twin-sharing scenarios and resource-limited healthcare settings.

研究设计

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

入排标准

年龄范围
1.00 Day(s) 至 3.00 Day(s)(—)
性别
All

入选标准

  • Neonate born in this institution at gestational age between 32 to 37 completed weeks with birth weight more than 1200 grams requiring thermal care in a twin sharing cot but not requiring any ionotrope support or mechanical ventillation and whose parents provided informed written consent.

排除标准

  • Neonates with major congenital anomalies or suspected chromosomal disorder or requiring incubator care or phototherapy or surgical intervention during study period and neonates with hemodynamic instability or severe respiratory distress and any neonate who is previously enrolled in another interventional study and neonates with non consenting parents.

结局指标

主要结局

Primary outcome is number of incidence or episode of neonatal hypothermia or hyperthermia.

时间窗: 3days

次要结局

  • Duration of SNCUstay,time to reach full enteral feeding,requirement and duration of respiratory support,occupancy of suspected or confirmed sepsis,neonatal mortality within 7 days(7 days)

研究者

发起方
DR ARPAN SAHA
申办方类型
Other [Self funding ]
责任方
Principal Investigator
主要研究者

Dr. Dinesh Munian

Medical College,Kolkata

研究点 (1)

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