Combined Volume Guarantee High-Frequency Oscillatory Ventilation (HFOV-VG) Versus Conventional High-Frequency Oscillatory Ventilation (HFOV) on Grade 2 to 3 Bronchopulmonary Dysplasia (BPD) or Death in Preterm Infants <32 Weeks With Respiratory Distress Syndrome (RDS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 348
- 主要终点
- Composite outcome of grade 2-3 BPD or in-hospital death at 36 weeks' PMA
研究概览
简要总结
Respiratory Distress Syndrome (RDS) remains the most common respiratory complication in the early postnatal period among preterm infants born before 32 weeks' gestational age. For this population, implementing lung-protective ventilation strategies is essential to shorten the duration of intubation, reduce the incidence and severity of bronchopulmonary dysplasia (BPD), lower mortality, and improve overall outcomes.
HFOV-VG was first reported in 2015 to be safely applied in neonates. The fundamental principle lies in its ability to stabilize the tidal volume of high-frequency ventilation (VThf), thereby reducing sheer stress from amplitude fluctuations, while simultaneously permitting lower VThf settings to minimize volutrauma.
This study aims to evaluate whether HFOV+VG is superior to HFOV in reducing the composite outcome of grade 2-3 BPD or death at 36 weeks' post-menstrual age (PMA).
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 (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age 24+0/7< 320/7 weeks
- •Diagnosis of RDS within 72 hours after birth, requiring endotracheal ventilation for both elective and rescue HFOV
排除标准
- •Severe birth defects: severe congenital heart disease, diaphragmatic hernia, gastrointestinal malformations, congenital brain developmental abnormalities, congenital pulmonary cysts
- •Uncorrected shock
- •Existence of grade 3-4 IVH before ventilated
- •Other conditions deemed unsuitable for enrollment by neonatologists, including endotracheal intubation performed specifically for the purpose of the INSURE or INRECSURE technique.
研究组 & 干预措施
HFOV
HFOV: 1) Mean airway pressure (MAP) and FiO2: titrated via oxygenation-guided lung recruitment maneuvers21-23 to maintain preductal SpO2 target of 89%-94%. 2) Frequency: 12-15 Hz for birth weight (BW)<1500g, and 10-12 Hz for BW≥ 1500g. 3) I:E ratio: 1:1 or 1:2 according to recommendations of manufacturers and local habits
干预措施: HFOV (Device)
HFOV+VG
HFOV-VG Group: ①VThf: <1000g 1.5-1.8ml/kg, 1000-1500g 1.8-2.2ml/kg, >1500g, 2.2-2.5ml/kg; ②Amplitude automatically adjusted by volume guarantee algorithm and the upper limit was set at 15% above the measured value after achieving the target VThf, with the constraint that it must not exceed 20 cm H2O for BW<1000g, 25cm H2O for BW 1000-1500g or 25-30 cmH2O for BW>1500g; ③If the target VThf is not achieved after the amplitude has reached its upper limit, airway issues (e.g., suctioning) or lung recruitment should be addressed first, rather than overriding the amplitude limit.
干预措施: HFOV+VG (Device)
结局指标
主要结局
Composite outcome of grade 2-3 BPD or in-hospital death at 36 weeks' PMA
时间窗: 36 weeks gestational age
次要结局
- In-hospital death at 36 weeks' PMA(36 weeks gestational age)
- The incidence of BPD at 36 weeks' PMA(36 weeks gestational age)
- The duration of invasive ventilation at the time of the first successful extubation(through study completion, an average of 1 year)
- The incidence of normocapnia, hypercapnia, and hypocapnia during the intervention period(through study completion, an average of 1 year)
- Surfactant doses(through study completion, an average of 1 year)
- Pulmonary hypertension (PH) requiring iNO treatment, including PPHN within 7 days after birth and cPH after 28 days of life(through study completion, an average of 1 year)
- hsPDA (Iowa score ≥6 )(through study completion, an average of 1 year)
- The incidence of massive pulmonary hemorrhage, pneumothorax, pneumomediastinum, pneumopericardium, and ventilator-associated pneumonia(VAP)(through study completion, an average of 1 year)
- The incidence of Grade III to IV IVH according to Papile 1978 criteria(through study completion, an average of 1 year)
- The incidence of Necrotizing enterocolitis (NEC) > grade II according to Modified Bell's Staging Criteria(through study completion, an average of 1 year)
- The incidence of Culture-proven late-onset sepsis (onset after 72 hours of life)(through study completion, an average of 1 year)
- The incidence of Retinopathy of premature > grade II(through study completion, an average of 1 year)
- The duration of hospitalization(through study completion, an average of 1 year)
- Weight gain (g/kg/day)(through study completion, an average of 1 year)
- The incidence of discharge against medical advice (DAMA)(through study completion, an average of 1 year)
研究者
Xingwang Zhu
Director
Jiulongpo No.1 People's Hospital