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

Use our guide to learn which trials are right for you!

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
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...
1221
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
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...
1965
mi
from 91732
Detroit, MI
Click here to add this to my saved trials
3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
2204
mi
from 91732
Durham, NC
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
2203
mi
from 91732
Durham, NC
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
1352
mi
from 91732
Houston, TX
Click here to add this to my saved trials
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...
1791
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
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...
1527
mi
from 91732
Iowa City, IA
Click here to add this to my saved trials
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
2320
mi
from 91732
Miami, FL
Click here to add this to my saved trials
2562
mi
from 91732
Providence, RI
Click here to add this to my saved trials
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....
2244
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
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...
572
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
648
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
Birmingham, Alabama 35294
1785
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Charlotte, North Carolina 27157
2129
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
Cincinnati, Ohio 45267
1880
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
2036
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
2486
mi
from 91732
New Haven, CT
Click here to add this to my saved trials
Palo Alto, California 94304
329
mi
from 91732
Palo Alto, CA
Click here to add this to my saved trials
San Diego, California 92093
99
mi
from 91732
San Diego, CA
Click here to add this to my saved trials