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

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Brief Title

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

Brief 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.

Study Phase

Phase 3

Study Type

Interventional

Condition

Bronchopulmonary Dysplasia

Intervention

dexamethasone

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

54

Start Date

November 1995

Eligibility Criteria

        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

Gender

All

Ages

N/A - 2 Weeks

Accepts Healthy Volunteers

No

Contacts

Richard C. Ahrens, ,

Administrative Informations

NCT ID

NCT00004785

Organization ID

199/11874

Secondary IDs

UIHC-69501

Study Sponsor

National Center for Research Resources (NCRR)

Collaborators

 University of Iowa

Study Sponsor

Richard C. Ahrens, Study Chair, University of Iowa

Verification Date

December 2001