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NCT00004785 Clinical Trial

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

Bronchopulmonary Dysplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004785
Other study ID # 199/11874
Secondary ID UIHC-69501
Status Completed
Phase Phase 3
First received February 24, 2000
Last updated June 23, 2005
Start date November 1995

Study information
Verified date December 2001
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 2 Weeks
Eligibility PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Premature infants with evolving bronchopulmonary dysplasia on chest x-ray Requirement for mechanical ventilation Fraction of inspired oxygen greater than 0.30 Ventilator at least 15 cycles/minute No signs of weaning within 72 hours prior to entry No serious congenital anomaly --Prior/Concurrent Therapy-- No prior postnatal corticosteroids --Patient Characteristics-- Cardiovascular: No congenital heart disease Other: Birth weight no greater than 1500 g Gestational age no greater than 30 weeks No contraindication to corticosteroids, e.g., culture-proven bacterial sepsis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• dexamethasone

• methylprednisolone

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) University of Iowa
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