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New hope for tiny lungs: simpler breathing treatment tested for premature babies in africa

NCT ID NCT06554522

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if giving surfactant (a natural substance that helps lungs stay open) through a less invasive method helps premature babies with breathing problems survive. About 1,500 babies weighing 1.5 to 4.4 pounds will receive this treatment in African hospitals that lack breathing machines. Researchers will track survival and complications to see if this simpler approach works better than standard care.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,512 people

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

Started

Jan 2025

Expected to finish

Dec 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

1 hour to 24 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: * Birth weight between 750 and 2000 grams or gestational age between 24- and 35 weeks. * Silverman Anderson Score ≥5 before or after CPAP treatment. * Admitted to a study site within 24 hours of life. Exclusion Criteria: * Major congenital or genetic anomalies. * Active pulmonary hemorrhage. * Major craniofacial anomalies that preclude the successful use of CPAP

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Conditions

The condition(s) this trial relates to.

newborn respiratory distress syndrome Premature Birth Pulmonary Atelectasis respiratory distress syndrome in premature infants

As listed by the trial registrant

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

Premature birth RDS of prematurity Respiratory distress syndrome in premature infant Surfactant deficiency syndrome neonatal

How to take part

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

  1. The places running it

    8 sites in 4 countries. 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

  • Centre Hospitalier Universitaire Communautaire

    NOT_YET_RECRUITING

    Bangui, Central African Republic

  • Coast General Teaching & Referral Hospital

    NOT_YET_RECRUITING

    Mombasa, Kenya

  • Federal Teaching Hospital Ido-Ekiti

    RECRUITING

    Ido-Ekiti, Ekiti State, Nigeria

  • Komfo Anokye Teaching Hospital

    NOT_YET_RECRUITING

    Kumasi, Ghana

  • Korle-Bu Teaching Hospital

    NOT_YET_RECRUITING

    Accra, Ghana

  • Mama Lucy Kibaki Hospital

    NOT_YET_RECRUITING

    Nairobi, Kenya

  • Tamale Teaching Hospital

    NOT_YET_RECRUITING

    Tamale, Ghana

  • University of Ilorin Teaching Hospital

    RECRUITING

    Ilorin, Kwara State, Nigeria

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