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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Non-invasive ventilation delivered through a nasal cannula as the respiratory interface for one hour after randomization in preterm infants after birth.
Non-invasive ventilation delivered through a single nasal prong as the respiratory interface for one hour after randomization in preterm infants after birth.
Rumah Sakit dr. Cipto Mangunkusumo
Jakarta, DKI Jakarta, Indonesia
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.
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
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
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
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
Interface Dislodgement
The proportion of infants experiencing dislodgement of the assigned non-invasive ventilation interface during the first hour after interface application.
Time frame: 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.
Time frame: At 1 hour after interface application
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