Randomized Controlled Trial of Two Protocols for Weaning From High Frequency Oscillatory Ventilation in Preterm Neonates With Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- comparing weaning failure rate between 2 groups
研究概览
简要总结
Our study is a randomized controlled trial that compares two weaning protocols of preterm infants with respiratory distress syndrome who are ventilated on high frequency oscillatory ventilation in order to establish the best weaning strategy with the least complications possible for this group of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with RDS whose gestational age is 34 weeks or less who required HFOV for more than 24 hours duration due to failure of non- invasive respiratory support due to any of the following:
- •Severe hypercapnea PaCO2 > 60 mmHg associated with pH < 7.
- •Hypoxemia PaO2 < 50 mmHg, with FiO2 > 40%.
- •Frequent apneas: 6 or more episodes of apnea requiring mild or moderate stimulation within 6-hour period or one apneic episode requiring bag and mask positive pressure ventilation.
排除标准
- •Preterm infants with any of the following :
- •Major congenital malformations or chromosomal aberrations.
- •Inborn errors of metabolism.
- •Severe intraventricular hemorrhage (IVH) grade III or IV
研究组 & 干预措施
Group 1 (intervention group)
Group I (Intervention group): Fifty five preterm infants with direct weaning from HFOV (high frequency oscillatory ventilation) to CPAP (continuous positive airway pressure).
干预措施: HFOV weaning protocol 1 (Other)
Group II (Control group)
Group II (Control group): Fifty five preterm infants with weaning from HFOV (high frequency oscillatory ventilation) to conventional mechanical ventilation (CMV) then to CPAP (continuous positive airway pressure) .
干预措施: HFOV weaning protocol 2 (Other)
结局指标
主要结局
comparing weaning failure rate between 2 groups
时间窗: 72 hours after weaning
Failure of weaning will be considered if the infant develops respiratory distress again requiring re-intubation within 72 hours after extubation due to any of the following: 1. Severe hypercapnia (PaCO2 \> 60 mmHg) . 2. Hypoxemia ( PaO2 \< 50 mm Hg). 3. Frequent apnea (6 apnea episodes within 6-hour period or 1 apneic episode requiring bag and mask positive pressure ventilation). Or escalation of respiratory support as following: 4. Titration of CPAP level out of the assigned range (CPAP pressure \> 8 cmH2O). 5. Escalation to an alternate mode of non-invasive respiratoy support such as non-invasive positive pressure ventilation (NIPPV).
次要结局
未报告次要终点
研究者
Yasmina Elsaied Hassan Keshta
assistant lecturer of pediatrics
Mansoura University Children Hospital