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

Starting soon · Not applicable

Conditions studied: Prematurity

In brief

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.

Key facts

Study ID

NCT07725614

Run by

Indonesia University

People needed

140

Starts

2026-07-20

Expected to finish

2027-07-20

Last updated by the study team

2026-07-24

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria:
• Preterm infants with a gestational age of 28 to <37 weeks who develop respiratory distress and require non-invasive ventilation (NIV) after birth.
• Written informed consent is obtained from a parent or legal guardian.

You may not qualify if…

• Infants with congenital nasal defects, including cleft lip and palate.
• Infants with prenatally diagnosed congenital anomalies that contraindicate NIV, including congenital diaphragmatic hernia, choanal atresia, esophageal atresia with tracheoesophageal fistula, or congenital heart disease.
• Infants with multiple congenital anomalies.
• Infants requiring endotracheal intubation for positive pressure ventilation immediately after birth.

Where it is running

• Rumah Sakit dr. Cipto Mangunkusumo — Jakarta, DKI Jakarta, Indonesia

Full record on ClinicalTrials.gov

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