An interventional study of Non-Invasive High-Frequency Oscillatory Ventilation and Conventional Mechanical Ventilation in Respiratory Distress Syndrome, sponsored by Muhammad Aamir Latif. Completed at 1 site in Pakistan. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Muhammad Aamir Latif · Not applicable, Interventional, and Treatment
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.
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).
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Muhammad Aamir Latif is the lead sponsor of 56 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Neonates were managed using a high-frequency oscillatory ventilator with a noninvasive nasal interface. Ventilator settings were adjusted to a mean airway pressure (MAP) of 8-12 cmH₂O, a frequency of 10 Hz, an amplitude adjusted to maintain optimal chest vibration, and an FiO₂ titrated to maintain SpO₂ between 90-94%.
Procedure: Non-Invasive High-Frequency Oscillatory Ventilation
Neonates received invasive ventilation through an endotracheal tube. Settings were adjusted to an initial tidal volume of 4-6 mL/kg, positive end-expiratory pressure (PEEP) of 4-6 cmH₂O, a respiratory rate of 30-50 breaths per minute, and FiO₂ titrated to maintain SpO₂ between 90-94%.
Procedure: Conventional Mechanical Ventilation
Neonates were managed using a high-frequency oscillatory ventilator with a noninvasive nasal interface. Ventilator settings were adjusted to a mean airway pressure (MAP) of 8-12 cmH₂O, a frequency of 10 Hz, an amplitude adjusted to maintain optimal chest vibration, and an FiO₂ titrated to maintain SpO₂ between 90-94%.
Neonates received invasive ventilation through an endotracheal tube. Settings were adjusted to an initial tidal volume of 4-6 mL/kg, positive end-expiratory pressure (PEEP) of 4-6 cmH₂O, a respiratory rate of 30-50 breaths per minute, and FiO₂ titrated to maintain SpO₂ between 90-94%.
Improvement in ventilation parameter
Improvement in ventilation parameter, measured by arterial blood gas analysis of the assigned ventilation modality was noted.
Time frame: 24 hours
Bronchopulmonary dysplasia
Bronchopulmonary dysplasia was considered 'yes' if the patient required supplemental oxygen (\>21% FiO₂) for ≥28 days to maintain oxygen saturation between 90-94%.
Time frame: 36 weeks post-menstrual age
Sepsis
At least 1 abnormality in laboratory findings of WBC \<5,000/mm³, I/T ratio \>0.2, and platelets \<100,000/mm³. or CRP elevated (\>10 mg/L), or procalcitonin elevated (\>2 ng/mL). or blood gas analysis metabolic acidosis (pH \<7.25) was taken as 'yes'.
Time frame: 28 days
Ventilator-Associated Pneumonia
Clinically, pneumonia was labeled 'yes' as a new or persistent respiratory distress or worsening gas exchange, increased ventilator requirements (e.g., higher FiO₂ or positive end-expiratory pressure \[PEEP\]), signs of infection (fever (\>38°C) or hypothermia (\<36°C), apnea or bradycardia episodes, tachycardia or hypotension).
Time frame: 48 hours
Duration of respiratory support
Total days on modality were noted.
Time frame: 28 days
Survival Status at Discharge
The survival status of the patient was noted as 'alive' or 'deceased'.
Time frame: 28 days
Plan to share: No — Data can be shared on a reasonable request.
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Muhammad Aamir Latif