Early surfactant administration at two different fractions of inspired oxygen thresholds: 40 percentage vs 30 percentage; in preterm neonates 26 to 34 weeks of gestation with respiratory distress syndrome on nCPAP: An open labelled randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion(%) of infants requiring intubation & mechanical ventilation in the first 72hrs of life
研究概览
简要总结
Respiratory Distress Syndrome is a common cause of respiratory distress in preterm neonates. Surfactant is main stay in the treatment of RDS. Depending on the severity of RDS, surfactant is instilled based on FiO2 requirement. European consensus guidelines states FiO2 requirement of 30% to administer surfactant. But there exist different recommendations regarding FiO2 threshold for receiving surfactant. This study is planned to address the uncertainty in determining the optimal FiO2 threshold for surfactant administration in preterm neonates with RDS. The aim of this study is to compare the effectiveness of two FiO2 thresholds ≥40% vs ≥30% for administering early surfactant in 26-34 weeks preterm neonates with respiratory distress syndrome on nCPAP in reducing the need for mechanical ventilation within 72hrs of life
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
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •All preterm neonates 26 0/7 to 33 6/7 weeks of gestation with respiratory distress syndrome requiring FiO2 of more than equal to 30% or of more than equal to 40% on nCPAP/NIV as the initial mode of respiratory support within 2hours of birth admitted to the NICU.
排除标准
- •1 Neonates requiring intubation in the delivery room or within two hours after birth 2 Life threatening congenital malformations 3 Other causes of respiratory distress other than RDS 4 APGAR less than 5 at 5min or cord gas pH less than 7 or base deficit of morethan equal to 16.
结局指标
主要结局
Proportion(%) of infants requiring intubation & mechanical ventilation in the first 72hrs of life
时间窗: First 72hrs of life
次要结局
- 1. Proportion of infants with death and BPD at 36 weeks of PMA(at 36 weeks PMA)
- 2. Duration of invasive ventilation support & oxygen support(During NICU stay)
- 3. Duration of CPAP support(During NICU stay)
- 4. Post surfactant CPAP settings PEEP and FiO2(12hrs after surfactant instillation)
- 5. Median time to receive surfactant(72hrs of life)
- 6. Total number of surfactant doses received(72hrs of life)
- 7. Oxygenation index, ratio of spO2 and FiO2, AaDo2 at day 3 of life(Day 3 of life)
- 8. Morbidities- late onset sepsis, hs-PDA, severe IVH (grade ≥2), PVL (grade ≥2), severe ROP (stage2), severe NEC (≥stage 2a)(During NICU stay)
- 9. Proportion of infants with air leaks, pneumothorax, pulmonary interstitial emphysema(During NICU stay)
- 10. Length of hospitalization in days(During NICU stay)
研究者
Thaslima Kalathingal
AIIMS Raipur