PEDIATRICS Vol. 117 No. 3 March 2006, pp. S52-S56 (doi:10.1542/peds.2005-0620I)
SUPPLEMENT ARTICLE |
Summary Proceedings From the Bronchopulmonary Dysplasia Group
a Department of Pediatrics, Case Western Reserve University, Rainbow Babies & Children’s Hospital, Cleveland, Ohio
b National Jewish Center for Immunology and Respiratory Medicine, Department of Pediatrics, University of Colorado Health Science Center, Denver, Colorado
c CardioPulmonary Research Institute Winthrop University Hospital, State University of New York, Stony Brook School of Medicine, Mineola, New York
d Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, Maryland
e Division of Newborn Medicine, Department of Pediatrics, Children’s Hospital of Boston and Harvard Medical School, Boston, Massachusetts
f Department of Pediatrics, Children’s Hospital, University of Colorado School of Medicine, Denver, Colorado
g Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland
h Department of Pediatrics, Children’s Hospital Medical Center, Cincinnati, Ohio
Despite improvements in neonatal care, bronchopulmonary dysplasia (BPD) continues to occur in approximately one third of newborns who have birth weights of <1000 g and contributes to significant morbidity in this population. Gaps in knowledge about the prevention and treatment of BPD remain, resulting in unintended short- and long-term sequelae. In addition to chronic lung disease, preterm newborns with BPD are more likely to develop language delay, cerebral palsy, and cognitive impairments compared with preterm newborns without BPD. The pulmonary group identified 3 critical needs to enhance the design of clinical trials in neonates with BPD: (1) identify the stages of BPD; (2) define BPD more clearly; and (3) identify subtypes of BPD patients. The group determined that trials are needed for 3 areas of BPD: (1) prevention of BPD; (2) treatment of evolving BPD; and (3) treatment of established BPD. The severity of BPD is defined as mild, moderate, and severe, and subgroups among those with BPD are described. Here we identify gaps in basic science and pharmacologic knowledge that hamper investigators' ability to conduct effective BPD clinical trials and provide a list of drugs to be studied in BPD trials. Priorities for drug-class evaluation by stage of BPD are given. The pulmonary group proposes a BPD clinical-trials framework that varies according to the different stages of BPD and describes characteristics of the overall design for BPD clinical trials. Finally, we discuss trial-design issues that are common to all neonatal studies.
Key Words: bronchopulmonary dysplasia • therapeutics
Abbreviations: BPD—bronchopulmonary dysplasia
Accepted Oct 17, 2005.
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