Non-invasive Secondary Respiratory Support in Late Preterm and Term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Failure rate
研究概览
简要总结
The aim of the present work is to compare between various modes of non-invasive respiratory support (including NCPAP, NIPPV, and NHFOV) as secondary respiratory support modes in late preterm and term neonates as regards the need for reintubation. Additionally, the study aims at comparing between the three modes concerning the associated morbidity and mortality.
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
- 年龄范围
- 1 Day 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The gestational age (GA) is between 34 and 41 weeks.
- •Extubation from invasive mechanical ventilation initiated due to RD, irrespective to the cause of RD.
- •Respiratory distress is assessed based on clinical manifestations (tachypnea, nasal flaring, intercostal retractions, diminished air entry, and or grunting)
排除标准
- •Major congenital anomalies.
- •Major cardiac diseases.
- •Presence of cardiovascular instability (sepsis, severe dehydration, severe anemia).
- •Neurologically insulted neonates who are unable to take adequate spontaneous breathing.
研究组 & 干预措施
Nasal intermittent pressure ventilation (NIPPV)
Neonates will be supported with NIPPV following extubation.
干预措施: NIPPV (Device)
Nasal high frequency ventilation (NHFOV)
Neonates will be supported with NHFOV following extubation. stating mean airway pressure 8 and can reach upto 15 cm H2O Delta pressure used is 20 Frequency 10 HZ
干预措施: NHFOV (Device)
Nasal Continuous positive airway pressure (NCPAP)
apply continuous positive airway pressure using nasopharyngeal interface. positive end expiratory pressure (PEEP ) used 5-7 cm H2O. Neonates will be supported with NCPAP following extubation.
干预措施: NCPAP (Device)
结局指标
主要结局
Failure rate
时间窗: 72 hours after weaning
need for reintubation and invasive mechanical ventilation
次要结局
- duration of non-invasive ventilation(first 72 hours after weaning from mechanical ventillation)
研究者
Marwa Mohamed Farag
Assistant professor of Pediatrics
Alexandria University