Comparative evaluation of surfactant administration techniques Less Invasive Surfactant Administration (LISA) vs. Intubation Surfactant Extubation (InSurE) in Preterm Infants with Respiratory Distress Syndrome: A randomized control study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Efficacy of LISA technique over InSurE
研究概览
简要总结
This study is a randomized, parallel group study aimed to do comparative evaluation of surfactant administration techniques - Less Invasive Surfactant Administration (LISA) vs Intubation Surfactant Extubation (InSurE) in preterm infants with respiratory distress syndrome. The study will be conducted in Sharda Hospital, Department of Pediatrics. The primary objective is Comparative evaluation of surfactant administration techniques - Less Invasive Surfactant Administration (LISA) vs Intubation Surfactant Extubation (InSurE) in preterm infants with respiratory distress syndrome and secondary objective is to assess the efficacy of LISA v/s InSurE through pulmonary outcomes –
Need for mechanical ventilation in the first 72 hours
Days on nCPAP
Need for two or more doses of surfactant
Length of hospital stay
Bronchopulmonary Dysplasia
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 2.00 Day(s)（—）
- 性别
- All
入选标准
- •Preterm infants less than 36 weeks which are fulfilling the criteria for RDS and are spontaneously breathing.
排除标准
- •Preterm neonates with Anatomical abnormalities of upper airway Congenital Diaphragmatic hernia Choanal atresia Trachea-oesophageal fistula Cleft palate.
- •Requiring intubation with invasive ventilation.
结局指标
主要结局
Efficacy of LISA technique over InSurE
时间窗: At 12 hours, 72 hours, throughout the study time period
次要结局
- need for two or more doses of surfactant(within 12 hours of birth)
- Need for mechanical ventilation(within 72 hours of birth)