Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000563
First received: October 27, 1999
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Lung Diseases
Respiratory Distress Syndrome
Drug: dexamethasone
Phase 3

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

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: June 1976
Study Completion Date: August 1983
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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000563

Sponsors and Collaborators
Investigators
Investigator: Charles Bauer University of Miami
Investigator: Richard Depp Northwestern University
Investigator: Sheldon Korones University of Tennessee
Investigator: Henrique Rigatto University of Manitoba
Investigator: Richard Zachman University of Wisconsin, Madison
  More Information

Publications:
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.

ClinicalTrials.gov Identifier: NCT00000563     History of Changes
Other Study ID Numbers: 201
Study First Received: October 27, 1999
Last Updated: April 26, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hyaline Membrane Disease
Lung Diseases
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014