Comparison of Methods of Weaning From Nasal CPAP in Preterm Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Successful weaning
研究概览
简要总结
This study aimed to determine the efficacy of different NCPAP weaning strategies in pre-term infants presenting with respiratory distress, and ultimately establishing the best method to withdraw from NCPAP.
详细描述
Pakistan, as well as other developing countries, lacks data regarding the weaning protocol of NCPAP. Ascertaining the best weaning method that could facilitate a shorter duration on nasal CPAP and the least length of hospital stay is very much needed. Findings of this study would help clinicians to achieve better outcomes for the patients receiving nasal CPAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants
- •Any gender
- •Low birth weight
- •Gestational ages between 28 to below 37 weeks
- •Presented with respiratory distress
- •Neonates with radiological findings suggestive of respiratory distress, congenital pneumonia/sepsis, or transient tachypnea of the newborn (TTN)
排除标准
- •Complex congenital abnormalities like diaphragmatic hernia, CNS malformations, intrapartum-related hypoxia, or congenital heart disease.
- •Intraventricular hemorrhage grade III or IV or low APGAR scores (<4 or 5 at 5 minutes)
研究组 & 干预措施
Sudden weaning of NCPAP
NCPAP was taken "off" entirely when the neonate met the "stability criteria" and remained on oxygen or room air via a headbox or incubator with an aim to stay off NCPAP.
干预措施: Sudden weaning of NCPAP (Procedure)
Gradual Weaning with increasing the time off NCPAP
The regimen adopted for this method was 1 hour off twice a day on the 1st day, then 2 hours off twice a day on the 2nd day, hence increasing the time off to 6 hours twice a day (or 12 hours per day), i.e., using a smaller period off. At this point, NCPAP was taken off completely.
干预措施: Gradual weaning with increasing the time off NCPAP (Procedure)
Pressure weaning of NCPAP
In this method the pressure was reduced in steps of 1 cm of H2O every 12 to 24 hours until 5 cm of H2O, and then if the child tolerated it well, NCPAP was removed, and the child was shifted to oxygen via incubator or room air according to the situation.
干预措施: Pressure weaning of NCPAP (Procedure)
结局指标
主要结局
Successful weaning
时间窗: 4 days
Weaning was considered as successful in the absence of pronounced retractions, tachypnea, or episodes of apnea and if there was no requirement for ventilator support after cessation of NCPAP support.
次要结局
- Hospital stay(25 days)
- Comparison of total days on NCPAP(4 days)