Nasal high frequency oscillation ventilation versus Nasal continuous positive airway pressure as primary respiratory support in preterm neonates of more than 30weeks gestation with Respiratory distress syndrome: an Open labelled Randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Treatment failure Defined as requirement of an use of an alternative NRS modality NIPPV or BiPAP,
研究概览
简要总结
This study will be conducted in a level 3 NICU in neonates born more than 30 weeks gestation, meeting the inclusion criteria. After attaining the consent, the neonate will be enrolled, assigned to respective groups after stratified randomization. Baseline characteristics will be recorded at enrolment. Treatment failure and need for IMV at 72 HOL will be observed as primary outcome.
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 30.00 Day(s)（—）
- 性别
- All
入选标准
- •preterm neonates of gestational age 30-36+6/7 weeks diagnosed with respiratory distress syndrome.
排除标准
- •neonates who had undergone endotracheal intubation or had received surfactant prior to randomization , neonates with gross congenital anomalies whose caretakers refuse to give consent to participate in study.
结局指标
主要结局
Treatment failure Defined as requirement of an use of an alternative NRS modality NIPPV or BiPAP,
时间窗: Treatment failure Defined as requirement of an use of an alternative NRS modality NIPPV or BiPAP, | Requirement of IMV within 72 hours of postnatal age
Requirement of IMV within 72 hours of postnatal age
时间窗: Treatment failure Defined as requirement of an use of an alternative NRS modality NIPPV or BiPAP, | Requirement of IMV within 72 hours of postnatal age
次要结局
- Requirement of surfactant replacement therapy, Pneumothorax, Mortality or BPD (defined as oxygen requirement at 28 days of postnatal age), Mortality, BPD (defined as oxygen requirement at 28 days of postnatal age), Duration of NRS support, Duration of IMV support, Duration of both NRS and IMV support, Duration of hospital stay, Severe intraventricular hemorrhage, Necrotizing enterocolitis stage 2 or more as per modified Bell’s staging, Retinopathy of prematurity (ROP) requiring intervention, Nasal injury(respiratory support started within 6hours)
研究者
Padamata Likhitha
Ankura hospital for women and children