New hope for tiniest babies: drug combo aims to prevent devastating lung disease

NCT ID NCT04545866

First seen Nov 11, 2025 · Last updated Apr 20, 2026 · Updated 17 times

Summary

This large Phase 3 trial is testing whether adding a steroid medication called budesonide to the standard lung treatment (surfactant) can help extremely premature babies. The goal is to reduce the combined risk of developing a serious chronic lung disease (Bronchopulmonary Dysplasia) or dying by 36 weeks of age. Over 600 infants born between 22 and 28 weeks will be randomly assigned to receive either the budesonide-surfactant combination or surfactant alone soon after birth.

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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

Conditions

Explore the condition pages connected to this study.