Summary Proceedings From the Bronchopulmonary Dysplasia Group
- 1 March 2006
- journal article
- Published by American Academy of Pediatrics (AAP) in Pediatrics
- Vol. 117 (Supplement), S52-S56
- https://doi.org/10.1542/peds.2005-0620i
Abstract
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.Keywords
This publication has 9 references indexed in Scilit:
- Prophylaxis of Early Adrenal Insufficiency to Prevent Bronchopulmonary Dysplasia: A Multicenter TrialPediatrics, 2004
- Safety, Reliability, and Validity of a Physiologic Definition of Bronchopulmonary DysplasiaJournal of Perinatology, 2003
- Moderately early (7-14 days) postnatal corticosteroids for preventing chronic lung disease in preterm infantsCochrane Database of Systematic Reviews, 2003
- Invited Review: Pulmonary alveoli: formation, the “call for oxygen,” and other regulatorsAmerican Journal of Physiology-Lung Cellular and Molecular Physiology, 2002
- Postnatal Corticosteroids to Treat or Prevent Chronic Lung Disease in Preterm InfantsPediatrics, 2002
- A Randomized Trial of Moderately Early Low-Dose Dexamethasone Therapy in Very Low Birth Weight Infants: Dynamic Pulmonary Mechanics, Oxygenation, and VentilationPediatrics, 2002
- Bronchopulmonary DysplasiaAmerican Journal of Respiratory and Critical Care Medicine, 2001
- Adverse Effects of Early Dexamethasone Treatment in Extremely-Low-Birth-Weight InfantsNew England Journal of Medicine, 2001
- Antenatal Glucocorticoid Treatment and Cystic Periventricular Leukomalacia in Very Premature InfantsNew England Journal of Medicine, 1999