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

NCT ID: NCT07307079

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-11-30

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).

Conditions

Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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%.

Group Type: EXPERIMENTAL

Non-Invasive High-Frequency Oscillatory Ventilation

Intervention Type: 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 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%.

Group Type: EXPERIMENTAL

Conventional Mechanical Ventilation

Intervention Type: 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%.

Interventions

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%.

Intervention Type: 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%.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muhammad Aamir Latif

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Aamir Latif

Research Consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Muhammad Farhan, FCPS

Role: PRINCIPAL_INVESTIGATOR

Indus Hospital - Recep Tayyip Erdogan Campus, Muzaffargarh

Athar Razzaq, FCPS

Role: STUDY_DIRECTOR

Indus Hospital - Recep Tayyip Erdogan Campus, Muzaffargarh

Locations

Indus Hospital - Recep Tayyip Erdogan Campus, Muzaffargarh

Muzaffargarh, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

DR-FARHAN-INDUS-HOSPITAL

Identifier Type: -

Identifier Source: org_study_id