Effectiveness of Non-Invasive High-Frequency Oscillatory Ventilation vs Conventional Ventilation for Preterm Neonates With Respiratory Distress Syndrome Following Nasal CPAP Failure.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Muhammad Aamir Latif
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Improvement in ventilation parameter
Overview
Brief Summary
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.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Neonates of any gender
- •Gestational age between 26 and 36 weeks
- •Diagnosed with RDS.
- •Failed to respond to nCPAP treatment
Exclusion Criteria
- •Major congenital anomalies like congenital diaphragmatic hernia, dysmorphism and congenital heart diseases
- •Early onset sepsis at the time of enrollment
Outcomes
Primary Outcomes
Improvement in ventilation parameter
Time Frame: 24 hours
Improvement in ventilation parameter, measured by arterial blood gas analysis of the assigned ventilation modality was noted.
Secondary Outcomes
- 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)
Investigators
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research