Effectiveness of Non-Invasive High-Frequency Oscillatory Ventilation vs Conventional Ventilation for Preterm Neonates With Respiratory Distress Syndrome Following Nasal CPAP Failure.
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
- 2
- 主要终点
- Improvement in ventilation parameter
研究概览
简要总结
Given the high burden of respiratory distress syndrome (RDS) and its complications in resource-constrained settings, identifying effective, low-risk interventions is imperative. The study aimed to assess the improvement in oxygenation and ventilation parameters initiating non-invasive high-frequency oscillatory ventilation (nHFOV) or conventional mechanical ventilation (CMV) and to compare the incidence of air leaks, sepsis, bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), prolonged hospital stays, and short-term survival rates.
详细描述
Global neonatal care is moving toward lung-protective ventilation strategies to improve outcomes for preterm neonates. Evaluating the role of nHFOV in low- and middle-income countries (LMICs) like Pakistan not only helps address local healthcare challenges but also contributes to global efforts to optimize neonatal care across diverse settings. To best of my knowledge no such type of study has been conducted in Pakistan. This study is non-invasive and cost effective. The findings of this study could inform policy decisions and resource allocation in NICUs across Pakistan and other middle-income countries (LMICs).
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
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates of any gender
- •Gestational age between 26 and 36 weeks
- •Diagnosed with RDS.
- •Failed to respond to nCPAP treatment
排除标准
- •Major congenital anomalies like congenital diaphragmatic hernia, dysmorphism and congenital heart diseases
- •Early onset sepsis at the time of enrollment
结局指标
主要结局
Improvement in ventilation parameter
时间窗: 24 hours
Improvement in ventilation parameter, measured by arterial blood gas analysis of the assigned ventilation modality was noted.
次要结局
- Bronchopulmonary dysplasia(36 weeks post-menstrual age)
- Sepsis(28 days)
- Ventilator-Associated Pneumonia(48 hours)
- Duration of respiratory support(28 days)
- Survival Status at Discharge(28 days)
研究者
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research