Safety, reliability, and validity of a physiologic definition of bronchopulmonary dysplasia.
OBJECTIVE
Bronchopulmonary dysplasia (BPD) is the focus of many intervention trials, yet the outcome measure when based solely on oxygen administration may be confounded by differing criteria for oxygen administration between physicians. Thus, we wished to define BPD by a standardized oxygen saturation monitoring at 36 weeks corrected age, and compare this physiologic definition with the standard clinical definition of BPD based solely on oxygen administration.


METHODS
A total of 199 consecutive very low birthweight infants (VLBW, 501 to 1500 g birthweight) were assessed prospectively at 36+/-1 weeks corrected age. Neonates on positive pressure support or receiving >30% supplemental oxygen were assigned the outcome BPD. Those receiving < or =30% oxygen underwent a stepwise 2% reduction in supplemental oxygen to room air while under continuous observation and oxygen saturation monitoring. Outcomes of the test were "no BPD" (saturations > or =88% for 60 minutes) or "BPD" (saturation < 88%). At the conclusion of the test, all infants were returned to their baseline oxygen. Safety (apnea, bradycardia, increased oxygen use), inter-rater reliability, test-retest reliability, and validity of the physiologic definition vs the clinical definition were assessed.


RESULTS
A total of 199 VLBW were assessed, of whom 45 (36%) were diagnosed with BPD by the clinical definition of oxygen use at 36 weeks corrected age. The physiologic definition identified 15 infants treated with oxygen who successfully passed the saturation monitoring test in room air. The physiologic definition diagnosed BPD in 30 (24%) of the cohort. All infants were safely studied. The test was highly reliable (inter-rater reliability, kappa=1.0; test-retest reliability, kappa=0.83) and highly correlated with discharge home in oxygen, length of hospital stay, and hospital readmissions in the first year of life.


CONCLUSIONS
The physiologic definition of BPD is safe, feasible, reliable, and valid and improves the precision of the diagnosis of BPD. This may be of benefit in future multicenter clinical trials.
D001997:Bronchopulmonary Dysplasia / Q000175:diagnosis* / Q000503:physiopathology* / Q000628:therapy; D023381:Endpoint Determination; D005240:Feasibility Studies; D006801:Humans; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight; D010100:Oxygen / Q000097:blood; D016896:Treatment Outcome
D010100:Oxygen