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

NCT00004785 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2005-06-24

No results posted yet for this study

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.

Conditions

  • Bronchopulmonary Dysplasia

Interventions

DRUG

dexamethasone

DRUG

methylprednisolone

Sponsors & Collaborators

  • University of Iowa

    collaborator OTHER

  • National Center for Research Resources (NCRR)

    lead NIH

Principal Investigators

  • Richard C. Ahrens · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
0 Years
Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-11-30

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004785 on ClinicalTrials.gov