Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07725614

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

Conditions: Prematurity

Sex: All
Ages: 0 Minutes – 6 Hours
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Indonesia University

Location: Rumah Sakit dr. Cipto Mangunkusumo Jakarta DKI Jakarta

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.

Eligibility Criteria

Inclusion Criteria: Inclusion Criteria: 1. Preterm infants with a gestational age of 28 to \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07725614). StuddyBuddy aggregates publicly available trial information.