drugset / Trial / NCT00004785

Phase III Randomized, Double-Blind Study of Dexamethasone Vs Dexamethasone/Methylprednisolone Vs Placebo for Bronchopulmonary Dysplasia

NCT00004785

RandomizedDouble-blindTreatment

Summary

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.

Timeline

Start
1995-11
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule Intravenous
Subject Methylprednisolone Other / unclassified Intravenous