A Comparative Study Between Postextubation of Preterm Infants Into High-Flow Nasal Cannulae V.S Nasal Continuous Positive Airway Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- postextubation respiratory support
研究概览
简要总结
The investigators hypothesize that there is a growing trend of the feasibility of HFNC as an alternative to other forms of non-invasive ventilation mechanism to provide continuous distending pressure to preterm infants. However, there remains uncertainty about the efficacy and safety of HFNC in this population.
详细描述
Our primary outcome is to determine whether postextubation respiratory support via heated humidified high-flow nasal cannula results in a greater proportion of infants younger than 34 weeks gestation being successfully extubated after a period of endotracheal positive pressure ventilation compared with conventional (NCPAP).
The following study will be conducted in the neonatal intensive care unit (NICU) of Gynecology and Obstetric department of Kasr El Aini hospital and neonatal intensive care unit of Military Hospital throughout a time interval of at least 6 months for a minimum of 100 preterm infants.
Infants will be eligible for the study if they born at less than 34 weeks' gestation, required endotracheal intubation and positive pressure ventilation, and considered ready for extubation by the clinical team.
The investigators will assign extubation of preterm ventilated infants (50 preterm infant) in NICU of Military Hospital into HHFNC and extubation of preterm ventilated infants (50 preterm infant) in (NICU) of Gynecology and Obstetric department of Kasr El Aini hospital into NCPAP (50 preterm infant).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born at a gestational age of less than 34 weeks, receiving mechanical ventilation through an endotracheal tube.
排除标准
- •Full term neonates or large for gestational age.
- •Preterm neonates not supported primarily by invasive ventilation.
- •Infants with suspected upper airway obstruction, congenital airway malformations or major cardiopulmonary malformations.
结局指标
主要结局
postextubation respiratory support
时间窗: through study completion, an average of 1 year
compare successful extubation of preterm (less than 34 weeks) into high flow nasal cannula versus continues positive airway pressure.
次要结局
- postextubation respiratory support follow up(through study completion, an average of 1 year)
研究者
Ramy Saleh Morsy
Assistatnt Lecturer in AFCM
Cairo University