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

NCT07307079 | Completed

• 1 other identifier: DR-FARHAN-INDUS-HOSPITAL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Improvement in ventilation parameter

  Improvement in ventilation parameter, measured by arterial blood gas analysis of the assigned ventilation modality was noted.

  24 hours

Secondary Outcomes (5)

• 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

Study Arms (2)

Non-Invasive High-Frequency Oscillatory Ventilation Group

EXPERIMENTAL

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

Conventional Ventilation Group

EXPERIMENTAL

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

Interventions

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%.

Conventional Ventilation Group

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%.

Non-Invasive High-Frequency Oscillatory Ventilation Group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates of any gender
• Gestational age between 26 and 36 weeks
• Diagnosed with RDS.
• Failed to respond to nCPAP treatment

You may not qualify if:

• Major congenital anomalies like congenital diaphragmatic hernia, dysmorphism and congenital heart diseases
• Early onset sepsis at the time of enrollment

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Indus Hospital - Recep Tayyip Erdogan Campus, Muzaffargarh

Muzaffargarh, Punjab Province, 32400, Pakistan

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Muhammad Farhan, FCPS

  Indus Hospital - Recep Tayyip Erdogan Campus, Muzaffargarh

  PRINCIPAL INVESTIGATOR

• Athar Razzaq, FCPS

  Indus Hospital - Recep Tayyip Erdogan Campus, Muzaffargarh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 29, 2025
• Study Start: June 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)