Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418353
Status:
COMPLETED
Last Update Posted:
2007-01-04
First Post:
2007-01-02
Brief Title:
Antenatal Betamethasone Compared to Dexamethasone - BETACODE TRIAL
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-01
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:
Antenatal corticosteroids result in substantial decrease in neonatal morbidity and mortality by specifically reducing the risk of respiratory distress syndrome intraventricular hemorrhage and neonatal death among premature infants No human randomized study has formally compared betamethasone and dexamethasone the preferred corticosteroids for antenatal therapy with regards to their effectiveness in reducing neonatal morbidities and mortality Our objective was to compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal morbidities and mortality among preterm infants
Detailed Description:
We conducted a double blind placebo-controlled randomized trial of antenatal betamethasone compared to dexamethasone among women at risk of preterm deliveries at Stony Brook University Hospital from August 1 2002 through July 31 2004 We excluded women with clinical chorioamnionitis major fetal structural anomalies fetal chromosomal abnormalities prior antenatal steroid exposure and use of betamethasone or dexamethasone for other medical indications quadruplets and higher order multiple gestation and those who declined enrollment Consenting women were randomly allocated to one of two groups by the Pharmacy using computer generated random numbers The statistical analysis was performed in accordance of the intention-to-treat principle Student t test Chi square and Fisher exact test were used for analysis A P value of 05 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None