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

Muhammad Aamir Latif

Status: Completed

Conditions: Respiratory Distress Syndrome

Treatments: Procedure: Conventional Mechanical Ventilation; Procedure: Non-Invasive High-Frequency Oscillatory Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT07307079

DR-FARHAN-INDUS-HOSPITAL

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Non-Invasive High-Frequency Oscillatory Ventilation Group

Experimental group

Description:

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%.

Treatment:

Procedure: Non-Invasive High-Frequency Oscillatory Ventilation

Conventional Ventilation Group

Experimental group

Description:

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%.

Treatment:

Procedure: Conventional Mechanical Ventilation