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NOT YET RECRUITING
NCT07725614
NA

Nasal Cannula Versus Single Nasal Prong for Non-Invasive Ventilation in Preterm Infants

Sponsor: Indonesia University

View on ClinicalTrials.gov

Summary

Preterm infants frequently require non-invasive ventilation (NIV) to treat respiratory distress after birth. The effectiveness of NIV may be influenced by the interface used to deliver respiratory support. Nasal cannula and single nasal prong are two interfaces commonly used for NIV; however, evidence directly comparing their efficacy during the early postnatal period remains limited. This randomized controlled trial aims to compare the efficacy of a nasal cannula and a single nasal prong as interfaces for non-invasive ventilation in preterm infants after birth. Eligible preterm infants requiring NIV after initial stabilization will be randomly assigned to receive respiratory support using either a nasal cannula or a single nasal prong. The assigned interface will be maintained for one hour following randomization, including during transport from the delivery room to the neonatal intensive care unit. The primary outcome is the need for endotracheal intubation within one hour after interface application. Secondary outcomes include the need for endotracheal intubation within 6 hour of age, respiratory effectiveness, assessed by the oxygen saturation index (OSI) and arterial blood gas parameters (pH and partial pressure of carbon dioxide \[pCO₂\]), as well as interface-related adverse events, including interface dislodgement and nasal injury. This study is expected to provide evidence to support the selection of an effective non-invasive ventilation interface for preterm infants after birth.

Official title: Nasal Cannula Versus Single Nasal Prong for Non-Invasive Ventilation in Preterm Infants After Birth: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

0 Minutes - 6 Hours

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-07-20

Completion Date

2027-07-20

Last Updated

2026-07-24

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Experimental, Intervention Name: Nasal Cannula

Non-invasive ventilation delivered through a nasal cannula as the respiratory interface for one hour after randomization in preterm infants after birth.

DEVICE

Active comparator: single nasal prong

Non-invasive ventilation delivered through a single nasal prong as the respiratory interface for one hour after randomization in preterm infants after birth.

Locations (1)

Rumah Sakit dr. Cipto Mangunkusumo

Jakarta, DKI Jakarta, Indonesia