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Can a steroid shot into the windpipe protect preemies' lungs?

NCT ID NCT07725575

Prevention 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether giving the steroid budesonide directly into the windpipe, together with surfactant, can prevent bronchopulmonary dysplasia — a chronic lung disease — in very preterm infants (born before 32 weeks or weighing under 1500 grams) who have respiratory distress syndrome. About 86 newborns will receive either budesonide plus surfactant or surfactant alone. Researchers will track lung health until 36 weeks after the mother's last menstrual period to see if the steroid lowers the chance of lung damage.

What this could mean

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

Active substance
budesonide (a corticosteroid) given into the windpipe along with surfactant
What this could lead to
If it works, this could offer a simple way to reduce chronic lung disease in the tiniest newborns.
What could go wrong
This is a single-center trial with 86 infants, so results may not apply everywhere. Corticosteroids in newborns carry risks, including possible effects on growth and development.

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

86 people

The number who actually took part.

Started

Nov 2024

Finished

Jun 2025

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

Up to 48 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: * newborn * birth weight less than 1500 g * gestational age less than 32 weeks * less than 48 hours of age * diagnosed as respiratory distress syndrome and need surfactant * get parental consent Exclusion Criteria: \- chromosom abnormality * critical congenital heart disease * congenital pulmonal disease * Need surgery within 1 month * mother with chorioamnionitis * received postnatal corticosteroid before

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Conditions

The condition(s) this trial relates to.

respiratory distress syndrome in premature infants bronchopulmonary dysplasia prevention target

As listed by the trial registrant

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

Bronchopulmonary dysplasia (BPD)

Contacts and locations

Locations

  • Cipto Mangunkusumo Hospital

    Jakarta, DKI Jakarta, 10430, Indonesia

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