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Which breathing tube works best for preterm infants? a trial puts two options to the test

NCT ID NCT07725614

Disease control Sponsor: Indonesia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial compares two common interfaces—a nasal cannula and a single nasal prong—used to deliver non-invasive breathing support to premature infants shortly after birth. Preterm babies who need help breathing will be randomly assigned to receive support through one of the two devices for one hour. The study aims to see which interface reduces the need for inserting a breathing tube, and whether one causes fewer side effects like nasal injury.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a nasal cannula or a single nasal prong as the interface for non-invasive ventilation
What this could lead to
If one interface proves better, it could reduce the need for intubation and improve breathing support for premature babies.
What could go wrong
This is a single-center trial with 140 infants, so results may not apply to all preterm populations. Both interfaces are already in use, so a clear winner is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 minutes to 6 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prematurity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rumah Sakit dr. Cipto Mangunkusumo

    Jakarta, DKI Jakarta, Indonesia

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