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Can a gentle breathing aid at birth save tiny lungs?

NCT ID NCT07162285

Disease control Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh 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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether giving bubble CPAP (a gentle breathing support) to preterm babies under 34 weeks within 10 minutes of birth helps them breathe better. Fifty-two babies will be randomly assigned to receive either bubble CPAP or standard oxygen in the delivery room. Researchers will compare how many need a ventilator, surfactant, or die early to see if early CPAP makes a difference.

What this could mean

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

Active substance
Bubble CPAP (a gentle breathing support device)
What this could lead to
If it works, this could show that starting bubble CPAP immediately after birth helps preterm babies breathe easier and reduces serious lung problems.
What could go wrong
This is a small, early-stage study with only 52 babies, so results may not apply to all preterm infants. The device may not reduce the need for a ventilator or prevent death.

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 52 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Oct 2026

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

5 to 30 minutes

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Neonate gestational age less than 34 weeks delivered at BSMMU. Having respiratory distress. Exclusion Criteria: * Congenital anomaly such as cleft lip, cleft palate, congenital diaphragmatic hernia. * Newborn required delivery room intubation

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Conditions

The condition(s) this trial relates to.

newborn respiratory distress syndrome Respiratory Distress Syndrome, Newborn

As listed by the trial registrant

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

Respiratory distress syndrome, newborn

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Nuzhat nuary Jui

    Dhaka, 1229, Bangladesh

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