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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prematurity
• Intervention / Treatment: Device: Experimental, Intervention Name: Nasal Cannula; Device: Active comparator: single nasal prong

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raden Adhi Teguh Perma Iskandar, Principal Investigator; Phone Number: 085779153162; Email: adhitpi@gmail.com
• Study Contact Backup: Name: Ina Rochayati; Phone Number: 087712526805; Email: inarochayati@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia
      • Rumah Sakit dr. Cipto Mangunkusumo
      • Contact: Raden Adhi Teguh Perma Iskandar, Principal Investigator; Phone Number: 085779153162; Email: adhitpi@gmail.com
      • Contact: Rochayati Ina; Phone Number: 087712526805; Email: inarochayati@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 with arm label: Nasal Cannula	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.
Active Comparator: Arm 2 with arm label: Single Nasal Prong	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The need for endotracheal intubation	The proportion of preterm infants requiring endotracheal intubation during the first hour after application of the assigned non-invasive ventilation interface.	Within 1 hour after interface application.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The need for Endotracheal Intubation	The proportion of preterm infants requiring endotracheal intubation by 6 hours of age.	By 6 hours of age
Oxygen Saturation Index (OSI)	Oxygen saturation index measured to assess respiratory effectiveness after 1 hour application of the assigned non-invasive ventilation interface.	At 1 hour after interface application
Partial Pressure of Carbon Dioxide (pCO₂)	Partial pressure of carbon dioxide (pCO₂) measured to evaluate ventilatory effectiveness at 1 hour after application of the assigned non-invasive ventilation interface.	At 1 hour after interface application
Blood pH	Blood pH measured to evaluate oxygenation effectiveness at 1 hour after application of the assigned non-invasive ventilation interface.	At 1 hour after interface application
Interface Dislodgement	The proportion of infants experiencing dislodgement of the assigned non-invasive ventilation interface during the first hour after interface application.	Within 1 hour after interface application
Title Nasal Injury	Description The proportion of infants developing nasal injury associated with the assigned non-invasive ventilation interface during the first hour after interface application.	At 1 hour after interface application

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 20, 2027

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 26-02-0251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No