Laryngeal mask airway Versus Endotracheal tube for Surfactant administration in Respiratory Distress Syndrome in Preterm neonates more than 30 weeks of gestation-A Randomized Control Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Need for mechanical ventilation within 48 hours of intervention
研究概览
简要总结
This study is a randomized, open labelled, parallel group, single-centred trail comparing the safety and efficacy of surfactant administration through laryngeal mask airway and endotracheal tube in preterm neonates more than 30 weeks of gestation. This study was designed based on the hypothesis that Surfactant administration through Laryngeal mask airway will decrease the need for intubation in babies with Respiratory distress syndrome , when compared to standard surfactant administration through endotracheal tube in preterm neonates more than 30 weeks of gestation.
Primary outcomes measured would be the need for mechanical ventilation within 48 hours of intervention. The secondary outcomes measured would be any need for mechanical ventilation, evaluation of pain scores (Neonatal Infant Pain score), duration of oxygen requirement, rate of pneumothorax, compilations related to the interventions, incidence of Sepsis and mortality rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 1.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Birth weight of more than 1200 grams 2.Gestational age of more than 30 weeks 3.Chronological age of less than 48 hours 4.Diagnosis of RDS with clinical and radiological criteria 5.Requiring nasal CPAP with Peep of less than 7 and FiO2 between 0.4 to 0.7 6.Hemodynamically stable A written consent will be obtained from the parents / care givers of the infant for willingness for enrolment in the study.
排除标准
- •1.Babies who underwent Endotracheal intubation earlier 2.Analgesia & or sedation during first 6 hours of life 3.APGAR score of less than 3 at 5 minutes of life 4.Babies with Major congenital anomalies.
结局指标
主要结局
Need for mechanical ventilation within 48 hours of intervention
时间窗: 48 hours
次要结局
- 1.Any need for mechanical ventilation(2.Evaluation of pain (Neonatal Infant Pain score))