Selective High Frequency Oscillation Ventilation(HFOV) vs Conventional Mechanical Ventilation(CMV) for Neonates With Acute Respiratory Distress Syndrome(ARDS):an Multicenters Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.The death rate is over 50%. HFOV and CMV are two main invasive ventilation strategies. However, which one is better needing to be further elucidated.
详细描述
Severe acute respiratory distress syndrome (ARDS) is one of the serious complications in critically ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. Usually, invasive ventilation with low parameters is enough for neonates with mild and moderate ARDS. And extracorporeal membrane oxygenation is used to neonates with severe ARDS. However, extracorporeal membrane oxygenation can also lead to high death rate and need more technique and conditions. Mechanical ventilation with higher parameters was a substitute for such situations, but the death rate, complications and injuries of higher parameters is unknown. The purpose of the present study was to compare HFOV with CMV as invasive respiratory support strategies on decrease the mortality and morbidities in neonate with ARDS.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Minute 至 12 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age (GA) between 25+0 and 34+0 weeks;
- •Assisted with CMV within 12 h after birth;
- •Diagnosis with ARDS;
- •Stabilization for 2 hours before randomization: FiO2 0.40, mean airway pressure (MAP) 10-14 cmH2O, ≤ 40 bpm of respiratory rate, 90%-94% of SpO2, pH > 7.20, PaCO2 60 mmHg and > 35% of hematocrit
排除标准
- •parents' decision not to participate;
- •Major congenital anomalies or chromosomal abnormalities;
- •Upper respiratory tract abnormalities;
- •need for surgery before randomization;
- •Grade Ⅲ-IV-intraventricular hemorrhage (IVH).
结局指标
主要结局
Death
时间窗: 28 days after birth or 36 weeks'gestational age or before discharge
the included preterm infants were dead
the incidence of bronchopulmonary dysplasia (BPD)
时间窗: 28 days after birth or 36 weeks'gestational age
the included neonate was diagnosed with BPD
次要结局
- the incidence of neonatal necrotizing enterocolitis(NEC)(28 days after birth or 36 weeks'gestational age or before discharge)
- the incidence of retinopathy of prematurity(ROP)(28 days after birth or 36 weeks'gestational age or before discharge)
- Intraventricular hemorrhage(28 days after birth or 36 weeks'gestational age or before discharge)
- composite mortality/BPD(28 days after birth or 36 weeks'gestational age or before discharge)
- the incidence of airleak(28 days after birth or 36 weeks'gestational age or before discharge)
研究者
Chen Long,MD
Principal Investigator
Children's Hospital of Chongqing Medical University