Phase III Randomized, Double-Blind Study of Dexamethasone Vs Dexamethasone/Methylprednisolone Vs Placebo for Bronchopulmonary Dysplasia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
|Study Start Date:||November 1995|
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.
|Study Chair:||Richard C. Ahrens||University of Iowa|