Health Trials

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

ConditionPrematurity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-6
SponsorIndonesia University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Arm 1 with arm label: Nasal CannulaExperimental treatment 1 intervention
Group B: Arm 2 with arm label: Single Nasal ProngActive comparator 1 intervention

Trial outcomes

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.

Time frame
Within 1 hour after interface application.

Secondary outcomes

1

The need for Endotracheal Intubation

The proportion of preterm infants requiring endotracheal intubation by 6 hours of age.

Time frame
By 6 hours of age
2

Oxygen Saturation Index (OSI)

Oxygen saturation index measured to assess respiratory effectiveness after 1 hour application of the assigned non-invasive ventilation interface.

Time frame
At 1 hour after interface application
3

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.

Time frame
At 1 hour after interface application
4

Blood pH

Blood pH measured to evaluate oxygenation effectiveness at 1 hour after application of the assigned non-invasive ventilation interface.

Time frame
At 1 hour after interface application

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indonesia University

Lead sponsor

Source ClinicalTrials.gov

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