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

NCT07725614 | Not Yet Recruiting

• 1 other identifier: 26-02-0251
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prematurity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The need for Endotracheal Intubation

  By 6 hours of age

• Oxygen Saturation Index (OSI)

  At 1 hour after interface application

• Partial Pressure of Carbon Dioxide (pCO₂)

  At 1 hour after interface application

• Blood pH

  At 1 hour after interface application

• Interface Dislodgement

  Within 1 hour after interface application

Study Arms (2)

Arm 1 with arm label: Nasal Cannula

EXPERIMENTAL

Device: Experimental, Intervention Name: Nasal Cannula

Arm 2 with arm label: Single Nasal Prong

ACTIVE COMPARATOR

Device: Active comparator: single nasal prong

Interventions

Experimental, Intervention Name: Nasal Cannula DEVICE

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

Arm 1 with arm label: Nasal Cannula

Active comparator: single nasal prong DEVICE

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

Arm 2 with arm label: Single Nasal Prong

Eligibility Criteria

• Age: 0 Minutes - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Rumah Sakit dr. Cipto Mangunkusumo

Jakarta, DKI Jakarta, Indonesia

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Raden Adhi Teguh Perma Iskandar, Principal Investigator

CONTACT

085779153162; adhitpi@gmail.com

Ina Rochayati

CONTACT

087712526805; inarochayati@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neonatologist

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 20, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)