NCT00000563

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 1976

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1976

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1983

Completed
16.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

First QC Date

October 27, 1999

Last Update Submit

April 26, 2012

Conditions

Lung DiseasesRespiratory Distress Syndrome

Interventions

dexamethasoneDRUG

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Male and female fetuses and infants; pregnant women with anticipated premature delivery and gestational age between 26 and 37 weeks.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • Effect of antenatal dexamethasone administration on the prevention of respiratory distress syndrome. Am J Obstet Gynecol. 1981 Oct 1;141(3):276-87.

    PMID: 7025638BACKGROUND

  • Effects of antenatal dexamethasone administration in the infant: long-term follow-up. J Pediatr. 1984 Feb;104(2):259-67. doi: 10.1016/s0022-3476(84)81009-4.

    PMID: 6363659BACKGROUND

  • Collaborative Group on Antenatal Steroid Therapy: Prevention of Respiratory Distress Syndrome: Effect of Antenatal Dexamethasone Administration. Hospital and Follow-up Studies. NIH Publication No. 85-2695, 1985.

    BACKGROUND

MeSH Terms

Conditions

Lung DiseasesRespiratory Distress Syndrome

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • 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

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

June 1, 1976

Study Completion

August 1, 1983

Last Updated

April 27, 2012

Record last verified: 2012-04