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Clinical trialNCT01353313CompletedPhase 3Interventional

Hydrocortisone for BPD

SponsorNICHD Neonatal Research NetworkEnrollment800Infant, NewbornInfant, Small for Gestational AgeInfant, Very Low Birth WeightInfant, PrematureBronchopulmonary Dysplasia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

20 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

  • University of California - Los Angeles

    Los Angeles, California, United States

  • Stanford University

    Palo Alto, California, United States

  • Emory University

    Atlanta, Georgia, United States

  • Indiana University

    Indianapolis, Indiana, United States

  • University of Iowa

    Iowa City, Iowa, United States

  • Wayne State University

    Detroit, Michigan, United States

  • Children'S Mercy Hospital

    Kansas City, Missouri, United States

  • University of New Mexico

    Albuquerque, New Mexico, United States

  • University of Rochester

    Rochester, New York, United States

  • Duke University

    Durham, North Carolina, United States

  • Rti International

    Durham, North Carolina, United States

  • Cincinnati Children'S Medical Center

    Cincinnati, Ohio, United States

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

    Cleveland, Ohio, United States

  • Research Institute at Nationwide Children'S Hospital

    Columbus, Ohio, United States

  • Univeristy of Pennsylvania

    Philadelphia, Pennsylvania, United States

  • Brown University, Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, United States

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, United States

  • University of Utah

    Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Hydrocortisone / lactatePlacebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
11 Aug 2011
Primary completion
21 Sept 2020
Completion
12 Sept 2024
Last update posted
27 Feb 2025
Registered enrollment
800
Registry id
NCT01353313

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.