Physiologic Definition of Bronchopulmonary Dysplasia

Summary

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).

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Bronchopulmonary Dysplasia (BPD)

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Michele C. Walsh, MD MS · Case Western Reserve University, Rainbow Babies & Children's Hospital

• Abbot R. Laptook, MD · Brown University, Women & Infants Hospital of Rhode Island

• Kurt Schibler, MD · Children's Hospital Medical Center, Cincinnati

• Ronald N. Goldberg, MD · Duke University

• Barbara J. Stoll, MD · Emory University

• Brenda B. Poindexter, MD MS · Indiana University

• Krisa P. Van Meurs, MD · Stanford University

• Ivan D. Franz, III, MD · Tufts Medical Center

• Waldemar A. Carlo, MD · University of Alabama at Birmingham

• Neil N. Finer, MD · University of California, San Diego

• Edward F. Bell, MD · University of Iowa

• Charles R. Bauer, MD · University of Miami

• Kristi L. Watterberg, MD · University of New Mexico

• Dale L. Phelps, MD · University of Rochester

• Roger G. Faix, MD · University of Utah

• Pablo J. Sanchez, MD · University of Texas, Southwestern Medical Center at Dallas

• Kathleen A. Kennedy, MD MPH · The University of Texas Health Science Center, Houston

• T. Michael O'Shea, MD MPH · Wake Forest University

• Seetha Shankaran, MD · Wayne State University

• Richard A. Ehrenkranz, MD · Yale University

• Abhik Das, PhD · RTI International

Eligibility

Min Age

36 Weeks

Max Age

37 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-05-31

Primary Completion

2008-05-31

Completion

2008-09-30

Countries

• United States

Study Locations