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Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration

NCT00000563 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-04-27

No results posted yet for this study

Summary

To determine the effect of corticosteroids, administered 24 to 48 hours before parturition, on the incidence of neonatal respiratory distress syndrome (RDS) and to determine whether the therapy has any adverse short- or long-term (up to 36 months) effects on the infant. Secondarily, to determine whether the therapy has any adverse short-term effects on the mother and to determine whether morbidity rates for neonatal respiratory distress syndrome as well as total and cause-specific infant mortality rates differ between mothers who received antenatal steroids and those who received conventional medical care.

Conditions

  • Lung Diseases
  • Respiratory Distress Syndrome

Interventions

DRUG

dexamethasone

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Charles Bauer · University of Miami

  • Richard Depp · Northwestern University

  • Sheldon Korones · University of Tennessee

  • Henrique Rigatto · University of Manitoba

  • Richard Zachman · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1976-06-30
Completion
1983-08-31

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Entities

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 NCT00000563 on ClinicalTrials.gov