Status:
COMPLETED
Physiologic Definition of Bronchopulmonary Dysplasia
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Infant, Newborn
Infant, Low Birth Weight
Eligibility:
All Genders
36-37 years
Brief 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...
Detailed Description
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,...
Eligibility Criteria
Inclusion
- 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
- Need for mechanical ventilation or continuous positive airway pressure (CPAP)
- Oxygen by hood \>30%
- Oxygen by nasal cannula \>30% effective oxygen
Key Trial Info
Start Date :
May 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT01223287
Start Date
May 1 2005
End Date
September 1 2008
Last Update
September 26 2017
Active Locations (21)
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1
University of Alabama
Birmingham, Alabama, United States, 35249-7335
2
Stanford University
Palo Alto, California, United States, 94304
3
University of California at San Diego
San Diego, California, United States, 92103-8774
4
Yale University
New Haven, Connecticut, United States, 06504