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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Procedure: Non-Invasive High-Frequency Oscillatory Ventilation; Procedure: Conventional Mechanical Ventilation

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Muzaffargarh, Punjab Province, Pakistan, 32400
      • Indus Hospital - Recep Tayyip Erdogan Campus, Muzaffargarh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-Invasive High-Frequency Oscillatory Ventilation Group; 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 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%.
Experimental: Conventional Ventilation Group; 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 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in ventilation parameter	Improvement in ventilation parameter, measured by arterial blood gas analysis of the assigned ventilation modality was noted.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	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'.	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).	48 hours
Duration of respiratory support	Total days on modality were noted.	28 days
Survival Status at Discharge	The survival status of the patient was noted as 'alive' or 'deceased'.	28 days

Collaborators and Investigators

• Sponsor: Muhammad Aamir Latif
• Investigators: Principal Investigator: Muhammad Farhan, FCPS, Indus Hospital - Recep Tayyip Erdogan Campus, Muzaffargarh; Study Director: Athar Razzaq, FCPS, Indus Hospital - Recep Tayyip Erdogan Campus, Muzaffargarh

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome
• Other Study ID Numbers: DR-FARHAN-INDUS-HOSPITAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared on a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No