Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration

NCT ID: NCT00000563

Last Updated: 2012-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1976-06-30
• Study Completion Date: 1983-08-31

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.

Detailed Description

BACKGROUND:

Neonatal respiratory distress syndrome is one of the leading causes of disability and death in the newborn. In the United States, approximately 10 percent of all infants are premature, and each year about 50,000 cases of neonatal respiratory distress syndrome occur.

Extensive studies in animal models on respiratory distress syndrome have demonstrated that antenatal administration of synthetic (dexamethasone) and natural (cortisol) corticosteroids accelerates lung maturation and significantly diminishes the occurrence of RDS. Although a variety of conditions in newborn infants have been treated with steroids over the past 20 years without adverse effects, investigations have been needed on the short-term effects of corticosteroids administered antenatally on neonate and mother and on the long-term effects on the infant.

The Planning Phase of this trial was completed in March 1977, with formulation of a common protocol and manual of operations. Patient screening and enrollment began in August 1977 and ended on March 1, 1980. Follow-up ended in August 1983 and data analysis was completed October 31, 1983.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample. Six hundred and ninety-six pregnant women were randomized to four doses of dexamethasone every 12 hours or to placebo. Endpoints were the incidence of respiratory distress syndrome and abnormality of motor-neuro-intellectual development in their infants.

Conditions

Lung Diseases; Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

dexamethasone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Male and female fetuses and infants; pregnant women with anticipated premature delivery and gestational age between 26 and 37 weeks.

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Principal Investigators

Charles Bauer

Role:

University of Miami

Richard Depp

Role:

Northwestern University

Sheldon Korones

Role:

University of Tennessee

Henrique Rigatto

Role:

University of Manitoba

Richard Zachman

Role:

University of Wisconsin, Madison

References

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

Reference Type: BACKGROUND

PMID: 7025638 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6363659 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

201

Identifier Type: -

Identifier Source: org_study_id