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COMPLETED
NCT07891494
PHASE4

Heated, Humidified High-flow Nasal (HHHFN) Cannula vs Nasal Continuous Positive Airway Pressure in Respiratory Distress in Premature Neonates

Sponsor: Pakistan Air Force (PAF) Hospital Islamabad

View on ClinicalTrials.gov

Summary

Newborn babies who have difficulty breathing may need breathing support to help them receive enough oxygen. Two commonly used methods are heated, humidified high-flow nasal cannula (HHFNC), which delivers warmed, moist air and oxygen through small tubes in the nose, and nasal continuous positive airway pressure (nCPAP), which helps keep the lungs open by delivering air and oxygen under gentle pressure through a nasal mask or tubes. This study will compare these two methods in newborn babies born at 28 weeks of pregnancy or later who develop breathing difficulties within the first 24 hours after birth. The study will be conducted in the neonatal intensive care unit at PAF Hospital Islamabad and will include 100 newborn babies. Participants will be randomly assigned to receive either HHFNC or nCPAP as their initial breathing support. The main purpose is to compare how often each method fails to provide adequate breathing support within the first 72 hours, requiring a change to another form of breathing support or insertion of a breathing tube for mechanical ventilation. The study will also assess other outcomes, including nasal injury, survival until hospital discharge, need for surfactant treatment, duration of breathing support and oxygen therapy, time to achieve full feeding, intestinal complications, and length of hospital stay. The findings may help improve understanding of the effectiveness and safety of these two breathing support methods in newborn babies with breathing difficulties.

Official title: To Compare the Clinical Efficacy of Heated, Humidified High-Flow Nasal Cannula (HHHFN) and Nasal Continuous Positive Airway Pressure (nCPAP), as Primary Respiratory Support in Neonates With Respiratory Distress Who Are≥28 Weeks GA in Reducing the Need for IMV

Key Details

Gender

All

Age Range

28 Weeks - 37 Weeks

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-09-04

Completion Date

2025-09-20

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Heated Humidified High-Flow Nasal Cannula therapy

HFNC will be provided by devices that deliver a blend of heated and humidified gas mixture of air and oxygen at gas flows exceeding 1 L/ min via binasal cannula

COMBINATION_PRODUCT

nCPAP

NCPAP will be provided by devices with pressure that is measurable and controllable that transport heated and humidified gas via binasal nasal prongs or nasal masks

Locations (1)

PAF Hospital Islamabad

Islamabad, Capital, Pakistan