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Completed

NCT Number: NCT07307079

Non-Invasive High-Frequency Oscillatory Ventilation vs Conventional Ventilation for Preterm Neonates.

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.

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Key information

Conditions

Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Tract Diseases

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indus Hospital - Recep Tayyip Erdogan Campus, Muzaffargarh

Muzaffargarh, Punjab Province, 32400, Pakistan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Invasive High-Frequency Oscillatory Ventilation

Procedure

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%.

Conventional Mechanical Ventilation

Procedure

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%.

Primary outcomes

  1. 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

  1. Bronchopulmonary dysplasia

    Time frame: 36 weeks post-menstrual age

    Bronchopulmonary dysplasia was considered 'yes' if the patient required supplemental oxygen (>21% FiO₂) for ≥28 days to maintain oxygen saturation between 90-94%.

  2. Sepsis

    Time frame: 28 days

    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'.

  3. Ventilator-Associated Pneumonia

    Time frame: 48 hours

    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).

  4. Duration of respiratory support

    Time frame: 28 days

    Total days on modality were noted.

  5. Survival Status at Discharge

    Time frame: 28 days

    The survival status of the patient was noted as 'alive' or 'deceased'.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

Effectiveness of Non-Invasive High-Frequency Oscillatory Ventilation vs Conventional Ventilation for Preterm Neonates With Respiratory Distress Syndrome Following Nasal CPAP Failure.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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