Dexamethasone Therapy in VLBW Infants at Risk of CLD

Summary

Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known. This trial looked at the benefits and hazards of starting dexamethasone therapy at two weeks of age and four weeks of age in premature infants.

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Bronchopulmonary Dysplasia

Interventions

DRUG

Dexamethasone Early

Tapering course of dexamethasone in doses given twice a day (0.25 mg per kilogram of body weight per dose for five days, then 0.15 mg, 0.07 mg, and 0.03 mg per kilogram per dose for three days each), followed by two weeks of saline.

DRUG

Dexamethasone Late

Saline for two weeks, followed by either the same tapering two-week course of dexamethasone given to the first group, if the respiratory-index score was \>=2.4 on treatment day 14, or an additional two weeks of saline

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Lu-Ann Papile, MD · University of New Mexico

• Jon E. Tyson, MD MPH · University of Texas Southwestern Medical Center

• Barbara J. Stoll, MD · Emory University

• Edward F. Donovan, MD · Children's Hospital Medical Center, Cincinnati

• Charles R. Bauer, MD · University of Miami

• Sheldon B. Korones, MD · University of Tennessee

• James A. Lemons, MD · Indiana University School of Medicine

• Avroy A. Fanaroff, MD · Rainbow Babies & Children's Hospital, Case Western Reserve University

• David K. Stevenson, MD · Stanford University

• Seetha Shankaran, MD · Wayne State University

• William Oh, MD · Women & Infants' Hospital, Brown University

• Richard A. Ehrenkranz, MD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

13 Days

Max Age

15 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1992-09-30

Primary Completion

1994-01-31

Completion

1994-04-30

Countries

• United States

Study Locations