Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration
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|ClinicalTrials.gov Identifier: NCT00000563|
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : April 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Lung Diseases Respiratory Distress Syndrome||Drug: dexamethasone||Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Study Start Date :||June 1976|
|Actual Study Completion Date :||August 1983|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000563
|OverallOfficial:||Charles Bauer||University of Miami|
|OverallOfficial:||Richard Depp||Northwestern University|
|OverallOfficial:||Sheldon Korones||University of Tennessee|
|OverallOfficial:||Henrique Rigatto||University of Manitoba|
|OverallOfficial:||Richard Zachman||University of Wisconsin, Madison|