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