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Clinical trialNCT01223287CompletedObservational

Physiologic Definition of Bronchopulmonary Dysplasia

SponsorNICHD Neonatal Research NetworkEnrollment410Bronchopulmonary Dysplasia (BPD)Infant, Low Birth WeightInfant, NewbornInfant, PrematureInfant, Small for Gestational Age
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This observational study was conducted to design and test a physiologic definition for bronchopulmonary dysplasia at 36 weeks of life. Infants were studied in a supine position with the pulse oximeter in position with good signal prior to collecting baseline data. Feedings and medications were given 30 minutes before the evaluation. Baseline data was collected on infant's current oxygen. Then, the infants were weaned to room air for 30 minutes. If saturations remain ≥90%, the infant was considered to have passed the oxygen reduction challenge (to NOT have BPD). The infant should then be placed back in his/her baseline oxygen. If the infant has saturations \<90% for 5 continuous minutes or \<80% for 15 seconds, the infant should be immediately placed back in his/her baseline oxygen, and the infant was considered to have NOT passed the challenge (to have BPD).

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

21 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

    Birmingham, Alabama, United States

  • Stanford University

    Palo Alto, California, United States

  • University of California at San Diego

    San Diego, California, United States

  • Yale University

    New Haven, Connecticut, United States

  • University of Miami

    Miami, Florida, United States

  • Emory University

    Atlanta, Georgia, United States

  • Indiana University

    Indianapolis, Indiana, United States

  • University of Iowa

    Iowa City, Iowa, United States

  • Tufts Medical Center

    Boston, Massachusetts, United States

  • Wayne State University

    Detroit, Michigan, United States

  • University of New Mexico

    Albuquerque, New Mexico, United States

  • University of Rochester

    Rochester, New York, United States

  • Wake Forest University

    Charlotte, North Carolina, 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

  • 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

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

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

Start
31 May 2005
Primary completion
31 May 2008
Completion
30 Sept 2008
Last update posted
26 Sept 2017
Registered enrollment
410
Registry id
NCT01223287

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.