Randomized Control Trial: Heated Humidity High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome in Extreme Low Birth Infants in Immediate Post Extubation Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- the need for re-intubation
研究概览
简要总结
To compare the primary outcome, failure of extubation defined by the need for re-intubation and mechanical ventilation within 5 days of initial extubation and secondary outcomes, morbidities and mortality after using of heated humidity high flow nasal cannula (HHHFNC) and Nasal Continuous Positive Airway Pressure (NCPAP) in the immediate post-extubation period for preterm infants between 24 and 28 weeks gestation with respiratory distress syndrome.
详细描述
Inclusion criteria were: 1) Preterm neonates with gestational age of 24 to 28 completed weeks. 2) In the case of twins, both neonates were included in the same treatment arm. 3) Success to wean with 24 hours to extubate. 4) Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.
Exclusion criteria were: 1) Evidence of severe birth asphyxia. 2) Known genetic or chromosomal disorders. 3) Infants delivered to mothers with ruptured membranes of more than three weeks duration. 4) Potentially life-threatening conditions unrelated to prematurity. 5) Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.
Randomization A computer-generated block-randomization sequence with random block sizes was used. Infants who were part of multiple births underwent individual randomization. Clinicians opened consecutively numbered, sealed, brown envelopes immediately before extubation to determine the study-group assignment.
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
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates with gestational age of 24 to 28 completed weeks.
- •In the case of twins, both neonates were included in the same treatment arm.
- •Success to wean with 24 hours to extubate.
- •Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.
排除标准
- •Evidence of severe birth asphyxia.
- •Known genetic or chromosomal disorders.
- •Infants delivered to mothers with ruptured membranes of more than three weeks duration.
- •Potentially life-threatening conditions unrelated to prematurity.
- •Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.
结局指标
主要结局
the need for re-intubation
时间窗: 5 DAYS
The primary outcome measured was failed extubation defined by the need for re-intubation and mechanical ventilation within five days of initial extubation.
次要结局
- Duration of respiratory support using HHHFNC /NCPAP.(through study completion, an average of 1 year.)
- Incidence of nasal breakdown(through study completion, an average of 24 weeks)
- intraventricular hemorrhage (IVH),(through study completion, an average of 24 weeks)
- retinopathy of prematurity (ROP)(through study completion, an average of 24 weeks)
- sepsis(through study completion, an average of 1 year.)
研究者
Mohammed Elkhwad
Principal investigator
Akron Children's Hospital