Physiologic Definition of Bronchopulmonary Dysplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

410 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

One of the confounders to any study that looks at bronchopulmonary dysplasia (BPD) is the lack of a precise definition. Most neonates with BPD do not undergo lung biopsy or any physiologic test; thus, their pulmonary disease is defined clinically, on the basis of the sustained need for supplemental oxygen at 36 weeks postmenstrual age. The validity of this definition is supported by evidence that oxygen dependence at 36 weeks is predictive of long-term impairment in pulmonary function. An inherent limitation of defining BPD by the need for supplemental oxygen is that the need for oxygen is determined by individual physicians, rather than on the basis of a physiologic assessment. Published literature cites acceptable saturation ranges from 88-98%.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Infant with birthweight 401-1500 grams
* Alive at 36+1 week corrected age
* On supplemental oxygen as follows:
* A. Infants receiving oxygen by hood at rest:
* A1. Oxygen by hood \<27% with majority\* of saturations ≥ 90% in prior 24 hours.
* A2. Oxygen by hood 27-30% with majority\* of saturations ≥ 96% in prior 24 hours
* B. Infants receiving oxygen by nasal cannula at restΔ:
* B1. Oxygen by nasal cannula \<27% EFFECTIVE\*\* oxygen and majority\* of saturations ≥90% in prior 24 hours.
* B2. Oxygen by nasal cannula 27-30% EFFECTIVE\*\* oxygen and majority\* saturations ≥96% on prior 24 hours.
* C. Infants receiving room air by nasal cannula at ANY liter per minute (lpm) flow.

Exclusion Criteria

* Need for mechanical ventilation or continuous positive airway pressure (CPAP)
* Oxygen by hood \>30%
* Oxygen by nasal cannula \>30% effective oxygen

Minimum Eligible Age

36 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michele C. Walsh, MD MS

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University, Rainbow Babies & Children's Hospital

Abbot R. Laptook, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University, Women & Infants Hospital of Rhode Island

Kurt Schibler, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Ronald N. Goldberg, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Barbara J. Stoll, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Brenda B. Poindexter, MD MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Krisa P. Van Meurs, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Ivan D. Franz, III, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Waldemar A. Carlo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Neil N. Finer, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Edward F. Bell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Charles R. Bauer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Kristi L. Watterberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Dale L. Phelps, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Roger G. Faix, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Pablo J. Sanchez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas, Southwestern Medical Center at Dallas

Kathleen A. Kennedy, MD MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

T. Michael O'Shea, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University

Seetha Shankaran, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Richard A. Ehrenkranz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Abhik Das, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama

Birmingham, Alabama, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

University of California at San Diego

San Diego, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Wake Forest University

Charlotte, North Carolina, United States

Site Status

RTI International

Durham, North Carolina, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Site Status

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Walsh MC, Yao Q, Gettner P, Hale E, Collins M, Hensman A, Everette R, Peters N, Miller N, Muran G, Auten K, Newman N, Rowan G, Grisby C, Arnell K, Miller L, Ball B, McDavid G; National Institute of Child Health and Human Development Neonatal Research Network. Impact of a physiologic definition on bronchopulmonary dysplasia rates. Pediatrics. 2004 Nov;114(5):1305-11. doi: 10.1542/peds.2004-0204.

Reference Type BACKGROUND

PMID: 15520112 (View on PubMed)