NCT00004785

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 0 Years – 2 Weeks
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	dexamethasone
DRUG	methylprednisolone

Timeline

• Start date: 1995-11-01
• First posted: 2000-02-25
• Last updated: 2005-06-24