An interventional study of Experimental, Intervention Name: Nasal Cannula and Active comparator: single nasal prong in Prematurity, sponsored by Indonesia University. Not yet recruiting at 1 site in Indonesia. Open to participants aged 0 Minutes to 6 Hours. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 140 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Experimental, Intervention Name: Nasal Cannula
Device: Active comparator: single nasal prong
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.
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jul 2027, 12 months later.
Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 12 months is below that.
Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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