Physiologic Definition of Bronchopulmonary Dysplasia



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:9/28/2017
Start Date:May 2005
End Date:September 2008

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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).

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).

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
We found this trial at
21
sites
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Dallas, TX
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Providence, RI
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Birmingham, Alabama 35294
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Charlotte, North Carolina 27157
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Cincinnati, Ohio 45267
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Palo Alto, California 94304
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San Diego, California 92093
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