Bronchopulmonary Dysplasia Clinical Trial
OBJECTIVES: I. Compare the efficacy of dexamethasone (DM) vs. DM/methylprednisolone
treatment vs. placebo, initiated within the first month of life, on long-term pulmonary and
developmental outcomes in premature infants with evolving bronchopulmonary dysplasia.
II. Compare the toxicities of these treatments. III. Assess treatment effects on adrenal
function.
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned
to 1 of 3 treatment groups. The first group receives intravenous dexamethasone tapered over
42 days.
The second group receives daily intravenous dexamethasone for 6 days, then intravenous
methylprednisolone (MePRDL) tapered over the next 34 days, beginning on day 8. A placebo is
given on "off" MePRDL days.
The third group receives an intravenous placebo for 42 days, with a tapering schedule
beginning day 35.
All patients may receive 6 days of dexamethasone rescue therapy beginning day 15 and/or 30,
as clinically indicated. Study drugs are suspended during rescue therapy.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
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