Use of self-inflating bag versus T piece resuscitator for resuscitation at the time of birth in preterm neonates—A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Need for delivery room intubation
研究概览
简要总结
This study is a randomized, open label, parallel group trial comparing the efficacy of T-piece resuscitator and self-inflating bag in providing positive pressure ventilation to newborns at birth. The study will be conducted on 136 newborns at the department of Neonatology, NIMS Hospital and Medical College, Jaipur, India. The primary outcome measure will the be need for delivery room intubation. The secondary outcomes The secondary outcomes will be the comparision of clinical outcomes in both groups such as -i. Duration of PPV, ii. Time to spontaneous breathing, iii. Time to achieve HR ≥100 bpm , iv. Saturation at 5 minutes of birth etc.
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 1.00 Day(s)（—）
- 性别
- All
入选标准
- •All the following should be fulfilled for enrolment: a) Inborn neonates (delivered at NIMS hospital, Jaipur) b) Gestational age 25 to 34 weeks c) Neonates that have not cried after birth and after initial steps require positive pressure ventilation due to apnea/gasping/heart rate less than 100 beats per minute d) Delivered vaginally, through Cesarean or via assisted delivery.
排除标准
- •Any one of the following a) Major congenital malformation (antenatally diagnosed or visible at birth) b) Refusal of consent by parents.
结局指标
主要结局
Need for delivery room intubation
时间窗: Discharge/ LAMA or Death of baby
次要结局
- Several clinical outcomes will be compared in both groups such as :(i. Duration of PPV)
研究者
Dr Sandeep Avasarala
NIMS University, Jaipur, Rajasthan