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New combo therapy aims to save tiny lungs

NCT ID NCT04545866

Disease control Sponsor: NICHD Neonatal Research Network 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether adding budesonide (an anti-inflammatory) to standard surfactant treatment helps extremely preterm babies avoid chronic lung disease or death. About 642 infants born before 29 weeks or weighing under 1000 grams will receive either the combo or surfactant alone within 48 hours of birth. The goal is to see if the combo reduces lung damage and improves survival.

What this could mean

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

Active substance
budesonide (an anti-inflammatory drug) combined with surfactant (a lung lubricant)
What this could lead to
If it works, this could reduce the risk of chronic lung disease or death in extremely premature babies.
What could go wrong
This is a single Phase 3 trial; results may not apply to all preterm infants. The combination could have side effects like infection or impaired lung 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

642 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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: * Liveborn infants 22 0/7 - 28 6/7 weeks gestation or 401 - 1000 grams (inclusive) birth weight * Clinical decision to give surfactant * Less than or equal to 48 hours postnatal age Exclusion Criteria: * Terminal illness (heart rate \< 100 beats per minute, unresponsiveness to resuscitation) or unlikely to survive as judged by the clinician * Decision to redirect or limit support * Use of surfactant before enrollment (first dose of surfactant must be study drug) * Infant received systemic steroids prior to enrollment * Use of indomethacin, either received by the mother within 24 hours prior to delivery,received by the infant prior to enrollment, or intent to administer to the infant for IVH prophylaxis or PDA management from enrollment up to 7 days of final dose of study drug * Serious chromosomal abnormalities or major malformations * Known congenital infections including, but not limited to, confirmed sepsis, congenital CMV, etc. * Infants with a permanent neuromuscular condition that affects respiration * Enrollment in a conflicting clinical trial

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Conditions

The condition(s) this trial relates to.

adult acute respiratory distress syndrome bronchopulmonary dysplasia Premature Birth respiratory distress syndrome in premature infants

As listed by the trial registrant

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

Bronchopulmonary dysplasia (BPD) Neonatal Prematurity; extreme Respiratory distress syndrome

Contacts and locations

Locations

  • Brown University - Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905, United States

  • Case Western Reserve University, Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106, United States

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio, 45267, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Emory University

    Atlanta, Georgia, 30303, United States

  • Northwestern Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • RTI International

    Durham, North Carolina, 27705, United States

  • Research Institute at Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California, 92123, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • University of Alabama

    Birmingham, Alabama, 35249-7335, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Mississippi Medical Center - Children's of Mississippi

    Jackson, Mississippi, 39216, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75235, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.