Published online November 1, 2004
PEDIATRICS Vol. 114 No. 5 November 2004, pp. 1305-1311 (doi:10.1542/peds.2004-0204)
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Impact of a Physiologic Definition on Bronchopulmonary Dysplasia Rates

Michele C. Walsh, MD, MS*, Qing Yao, PhD{ddagger}, Patricia Gettner, RN§, Ellen Hale, RN||, Monica Collins, RN, Angelita Hensman, RN#, Ruth Everette, RN**, Nancy Peters, RN{ddagger}{ddagger}, Nancy Miller, RN§§, Gerry Muran, RN||||, Kathy Auten, BS¶¶, Nancy Newman, RN*, Gina Rowan, RN##, Cathy Grisby, RN***, Kathy Arnell, RN{ddagger}{ddagger}{ddagger}, Lucy Miller, RN§§§, Bethany Ball, BS||||||, Georgia McDavid, RN¶¶¶ for the National Institute of Child Health and Human Development Neonatal Research Network

* Department of Pediatrics, Case Western Reserve University, Cleveland, Ohio
{ddagger} Department of Pediatrics, Research Triangle Institute, Research Triangle Park, North Carolina
§ Department of Pediatrics, Yale University, New Haven, Connecticut
|| Department of Pediatrics, Emory University, Atlanta, Georgia
Department of Pediatrics, University of Alabama, Birmingham, Alabama
# Department of Pediatrics, Brown University, Providence, Rhode Island
** Department of Pediatrics, University of Miami, Miami, Florida
{ddagger}{ddagger} Department of Pediatrics, Wake Forest University, Winston-Salem, North Carolina
§§ Department of Pediatrics, University of Texas, Southwestern, Dallas, Texas
|||| Department of Pediatrics, Wayne State University, Detroit, Michigan
¶¶ Department of Pediatrics, Duke University, Durham, North Carolina
## Department of Pediatrics, University of Rochester, Rochester, New York
*** Department of Pediatrics, University of Cincinnati, Cincinnati, Ohio
{ddagger}{ddagger}{ddagger} Department of Pediatrics, Sharp Mary Birch Hospital, San Diego, California
§§§ Department of Pediatrics, Indiana University, Indianapolis, Indiana
|||||| Department of Pediatrics, Stanford University, Palo Alto, California
¶¶¶ Department of Pediatrics, University of Texas, Houston, Texas

Objective. Bronchopulmonary dysplasia (BPD) is the endpoint of many intervention trials in neonatology, yet the outcome measure when based solely on oxygen administration may be confounded by differing criteria for oxygen administration between physicians. We previously reported a technique to standardize the definition of BPD between sites by using a timed room-air challenge in selected infants. We hypothesized that a physiologic definition of BPD would reduce the variation in observed rates of BPD among different neonatal centers.

Methodology. A total of 1598 consecutive inborn premature infants (501–1249 g birth weight) who remained hospitalized at 36 weeks' postmenstrual age were prospectively assessed and assigned an outcome with both a clinical definition and physiologic definition of BPD. The clinical definition of BPD was oxygen supplementation at exactly 36 weeks' postmenstrual age. The physiologic definition of BPD was assigned at 36 ± 1 weeks' postmenstrual age and included 2 distinct subpopulations. First, neonates on positive pressure support or receiving >30% supplemental oxygen with saturations between 90% and 96% were assigned the outcome BPD and not tested further. Second, those receiving ≤30% oxygen or effective oxygen >30% with saturations >96% underwent a room-air challenge with continuous observation and oxygen-saturation monitoring. Outcomes of the room-air challenge were "no BPD" (saturations ≥90% during weaning and in room air for 30 minutes) or "BPD" (saturation <90%). At the conclusion of the room-air challenge, all infants were returned to their baseline oxygen levels. Safety (apnea, bradycardia, increased oxygen use) and outcomes of the physiologic definition versus the clinical definition were assessed.

Results. A total of 560 (35.0%) neonates were diagnosed with BPD by the clinical definition of oxygen use at 36 weeks' postmenstrual age. The physiologic definition diagnosed BPD in 398 (25.0%) neonates in the cohort. All infants were safely studied. There were marked differences in the impact of the definition on BPD rates between centers (mean reduction: 10%; range: 0–44%). Sixteen centers had a decrease in their BPD rate, and 1 center had no change in their rate.

Conclusions. The physiologic definition of BPD reduced the overall rate of BPD and reduced the variation among centers. Significant center differences in the impact of the physiologic definition were seen, and differences remained even with the use of this standardized definition. The magnitude of the change in BPD rate is comparable to the magnitude of treatment effects seen in some clinical trials in BPD. The physiologic definition of BPD facilitates the measurement of BPD as an outcome in clinical trials and the comparison between and within centers over time.

Key Words: premature infant • bronchopulmonary dysplasia • chronic lung disease • test • methodology

Abbreviations: VLBW, very low birth weight • BPD, bronchopulmonary dysplasia • lpm, liters per minute • STOP-ROP, Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity • FIO2, fraction of inspired oxygen • IRB, institutional review board

Accepted May 20, 2004.




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