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

This study has been completed.
University of Iowa
Information provided by:
Office of Rare Diseases (ORD) Identifier:
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001

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.

Condition Intervention Phase
Bronchopulmonary Dysplasia Drug: dexamethasone Drug: methylprednisolone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 54
Study Start Date: November 1995
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.


Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

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Please refer to this study by its identifier: NCT00004785

Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Iowa
Study Chair: Richard C. Ahrens University of Iowa
  More Information Identifier: NCT00004785     History of Changes
Other Study ID Numbers: 199/11874
Study First Received: February 24, 2000
Last Updated: June 23, 2005

Keywords provided by Office of Rare Diseases (ORD):
bronchopulmonary dysplasia
cardiovascular and respiratory diseases
neonatal disorders
rare disease

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Dexamethasone acetate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors processed this record on July 27, 2017