New combo therapy aims to save tiny lungs

NCT ID NCT04545866

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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