High-Frequency Oscillation Ventilation Versus Conventional Mechanical Ventilation in Very Preterm Infants With Perinatal Acute Respiratory Distress Syndrome: Multicenters Randomized Controlled, Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- the incidence of bronchopulmonary dysplasia(BPD)
研究概览
简要总结
Bronchopulmonary dysplasia (BPD) is a complex disorder and remains the most common complication in very preterm infants. Its incidence is increased with gestational age from 95.5% among infants born at 22 weeks' gestation to 22.2% among those born at 29 weeks' gestation. BPD is associated with the increased risks of delayed neurodevelopment and pulmonary impairment. High incidences of BPD and morbidities indicate inadequacy of current management guidelines of BPD.3 Caffeine reduces the development of BPD by lowering the duration of intubation.4 How to further reduce the risk of BPD and the duration of invasive ventilation remain the key focus for neonatologists.
详细描述
Before 2017, the management guideline of pediatric and adult acute respiratory distress syndrome (ARDS) exclude perinatal triggers-induced ARDS. Moreover, there is insufficient evidence to recommend high-frequency oscillatory ventilation (HFOV) or conventional mechanical ventilation (CMV) as the preferred fist-line therapy in pediatric and adult ARDS. In contrast, HFOV may benefit preterm baboons with acute pulmonary dysfunction-typically due to respiratory distress syndrome (RDS)-by using low tidal volume, supra-physiologically higher respiratory rate, and lower peak inspiratory pressure to enhance oxygenation and gas exchange. The team also reported that use of HFOV is associated with a modest reduction referring to BPD. However, European consensus guideline of RDS only recommend HFOV being a reasonable alternative to CMV when high pressure is needed to achieve adequate lung inflation. Because randomized controlled trials in humans have yielded inconsistent findings.
These differences between animal models-where RDS was induced and treated with surfactant alone-and clinical scenarios, where preterm birth often involved complex etiologies requiring both surfactant and antibiotics for placental insufficiency or intrauterine infection, may be the diagnosis of RDS and ARDS or the mixture of RDS and ARDS. Such findings highlighted the lack of robust evidence for optimizing ventilation strategies in preterm infants born <32 weeks with perinatal ARDS, and the need for well-designed multi-center randomized controlled trials in this high-risk population.
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)
盲法说明
The caregivers will not be blinded, and the outcome assessors and data analysts will be blinded to the intervention.
入排标准
- 年龄范围
- 1 Minute 至 1 Hour（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GA was between 24+0 and 31+6 weeks.
- •Preterm neonates were admitted to NICU within 1 hours after birth, diagnosed with perinatal ARDS using Montreux guidelines and stable supported by CMV.
- •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, tidal volume of 5 ml/kg and > 35% of hematocrit (these may be evaluated by arterial blood gas analysis).
排除标准
- •Neonates were not included if any of the following criteria were met:
- •Parents or guardians' decision not to participate.
- •Major congenital anomalies or chromosomal abnormalities
- •Need for surgery or more than grade 2nd of IVH before randomization.
结局指标
主要结局
the incidence of bronchopulmonary dysplasia(BPD)
时间窗: 36 weeks' gestational age
BPD is defined according to the 2019 diagnostic criteria. For infants discharged before 36 weeks' GA, BPD severity was assessed based on respiratory support at the time of discharge. Infants receiving no supplemental respiratory support were divided into no BPD, those treated with nasal cannula (≤ 2 L/min) as grade 1 BPD, those treated with nasal cannula (\> 2 L/min) or noninvasive positive airway pressure as grade 2 BPD and those treated with invasive mechanical ventilation as grade 3 BPD.
the incidence of bronchopulmonary dysplasia(BPD)
时间窗: 36 weeks' gestational age
BPD is defined according to the 2019 diagnostic criteria. For infants discharged before 36 weeks' GA, BPD severity was assessed based on respiratory support at the time of discharge. Infants receiving no supplemental respiratory support were divided into no BPD, those treated with nasal cannula (≤ 2 L/min) as grade 1 BPD, those treated with nasal cannula (\> 2 L/min) or noninvasive positive airway pressure as grade 2 BPD and those treated with invasive mechanical ventilation as grade 3 BPD.
次要结局
- duration of invasive ventilation(36 weeks' gestational age)
- duration of invasive ventilation(36 weeks' gestational age)
- mortality(36 weeks' gestational age or before discharge)
- air leak (pneumothorax and/or pneumomediastinum) occurred(36 weeks' gestational age or before discharge)
- the incidence of hemodynamically significant patent ductus arteriosus (hsPDA)(36 weeks' gestational age or before discharge)
- the incidence of retinopathy of prematurity(ROP)> 2nd grades(36 weeks' gestational age or before discharge)
- the incidence of necrotizing enterocolitis(NEC)≥2nd stages(36 weeks' gestational age or before discharge)
- intraventricular hemorrhage(IVH)>2nd grade(36 weeks' gestational age or before discharge)
研究者
Chen Long,MD
Principal Investigator
Children's Hospital of Chongqing Medical University