Clinical efficacy of t piece resuscitator versus selfinflating bag for resuscitation in preterm neonates requiring positive pressure ventilation at birth: a randomized controlled trial
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
Dr Ruchika Bhatnagar
Government Institute of Medical Sciences (GIMS)
