Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000563
Status:
COMPLETED
Last Update Posted:
2012-04-27
First Post:
1999-10-27
Brief Title:
Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 50000 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
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 50000 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: