No-CPAP versus CPAP in late preterm and term neonates with mild respiratory distress: A non-inferiority parallel group open-label randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- To determine the duration of respiratory support in late-preterm and term neonates with mild respiratory distress, managed with No-CPAP vs. CPAP in the delivery room at birth
研究概览
简要总结
Late pre-term (34 weeks, 0/7 days to 36 weeks, 6/7 days of gestation) and term neonates (37 weeks 0/7 days to 41 weeks 6/7 days of gestation) with mild respiratory distress defined as Silverman-Andersson score of 1-3 will be included in the study. The neonates will be randomized into two groups at 10 to 15 minutes of life. The first group will receive No-CPAP support and the second group will receive CPAP support. The positive end expiratory pressure (PEEP) will be applied at 5 cm of water (in CPAP group only) to begin with. The neonates will be monitored every 15 minutes for first 1 hour. At 1 hour of life, neonate from both the groups having any distress defined as Silverman-Andersson score ≥1 or requirement of supplemental oxygen will be admitted to NICU.
If any neonate at or earlier than 1 hour of life will have respiratory deterioration, with Silverman-Andersson score of ≥4, will be admitted to NICU and managed according to protocol.
In the NICU the respiratory support will be hiked in case of any increase in respiratory distress. Supplemental oxygen will be provided in case of hypoxia.The respiratory support will be removed after resolution of respiratory distress (Silverman-Andersson score of 0) and oxygen saturation is in normal range (≥ 91%) in absence of supplemental oxygen. The neonate will be considered off respiratory support if there will be no further requirement of CPAP support or supplemental oxygen for 24 hours after removal of respiratory support.
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
- •Late pre-term (34 weeks,0/7 days to 36 weeks,6/7 days of gestation) and term neonates (37 weeks, 0/7 to 41 weeks 6/7 days of gestation) with mild respiratory distress defined as Silverman-Anderson score of 1-3 at birth.
排除标准
- •1.Requirement of positive pressure ventilation for more than 30 seconds at birth 2.Perinatal asphyxia – Apgar score of less than 7 at one minute of life 3.Babies born with meconium-stained liquor 4.Maternal chorioamnionitis 5.Suspected or known major congenital malformation or any malformation that interferes with intervention and outcome 6.Requirement of NICU admission for any cause other than transient tachypnea of newborn.
结局指标
主要结局
To determine the duration of respiratory support in late-preterm and term neonates with mild respiratory distress, managed with No-CPAP vs. CPAP in the delivery room at birth
时间窗: From institution to removal of respiratory support
次要结局
- Need for neonatal intensive care unit (NICU) admission(From randomization to decision for neonatal intensive care unit (NICU) admission)
- Escalation of respiratory support(From randomization to shifting out of neonatal intensive care unit (NICU))
- Incidence of air leak e.g. pneumothorax(From randomization to discharge from hospital)
- Duration of neonatal intensive care unit (NICU) stay(Total duration of NICU stay calculated from NICU admission to shifting out of NICU)
- Duration of hospital stay(Total duration of hospital stay calculated from day of birth to the day of hospital discharge)
研究者
Ritesh Ranjan Sah
AIl India Institute of Medical Sciences, New Delhi