跳至主要内容
临床试验/CTRI/2025/09/094959
CTRI/2025/09/094959招募中不适用

Clinical efficacy of t piece resuscitator versus selfinflating bag for resuscitation in preterm neonates requiring positive pressure ventilation at birth: a randomized controlled trial

Government Institute of Medical Sciences Greater Noida1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2025年10月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
170
试验地点
1
主要终点
Delivery room intubation rate

研究概览

简要总结

A systematic review conducted by Roehr et al (2021) 5 on comparison of effectiveness of T piece vs SIB in neonatal care. in pediatric journal by Roehr and Davis had a scoping review that compared the effectiveness of T-piece resuscitator (TPR) and self-inflating bag (SIB) in neonatal care. Analyzing four key studies with 2889 neonates, the review found no significant difference in overall survival or air leak incidence between TPR and SIB groups. However, TPR showed potential benefits in preterm infants, including lower delivery room intubation rates, reduced bronchopulmonary dysplasia, and higher survival rates. While randomized controlled trials didn’t demonstrate statistically significant superiority of TPR, the consistent trend favoring TPR, especially in preterm infants, suggests potential clinical benefits. The review highlights the need for further research to confirm these findings and explore the advantages of TPR in specific neonatal populations.

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
0.50 Day(s) 至 1.00 Day(s)(—)
性别
All

入选标准

  • Neonates born in this tertiary care irrespective of mode of delivery will be eligible for enrolment if they fulfil the following inclusion criteria: Neonates with gestational age of less than
  • not breathing apneic or gasping.
  • Neonates with Heart Rate less than 100 beats per minute after completion of initial steps of neonatal resuscitation.

排除标准

  • Neonates with any of the following conditions will be excluded: 1.Major congenital malformation for example congenital diaphragmatic hernia, central cleft lip, Cleft Palate 2.Major CNS malformations For example Meningomyelocele
  • Twin gestation.

结局指标

主要结局

Delivery room intubation rate

时间窗: At the time of enrollment day 1

次要结局

  • Duration of NICU stay(-Need of surfactant)

研究者

发起方
Government Institute of Medical Sciences Greater Noida
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ruchika Bhatnagar

Government Institute of Medical Sciences (GIMS)

研究点 (1)

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