Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187382
Status:
COMPLETED
Last Update Posted:
2010-06-15
First Post:
2005-09-13
Brief Title:
Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study MACS
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study MACS
Status:
COMPLETED
Status Verified Date:
2010-06
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:
In women at 26 to 30 weeks gestation and who are risk for threatened early birth who have not had their baby by 14 or more days after being given a single course of antenatal corticosteroids ACS do repeated courses of ACS every 14 days until 33 weeks gestational age lower the risk of illness or death in babies compared to repeated courses of placebo Children are assessed at 2 years and 5 years for neurodevelopmental impairment
Detailed Description:
In women at 26 to 30 weeks gestation who are at increased risk for preterm birth and remain undelivered 14 or more days following a single course of antenatal corticosteroids ACS are multiple course of ACS every 14 days until 33 weeks effective in reducing the risk of perinatal or neonatal mortality or significant neonatal morbidity compared to placebo
18-24 Month Follow-up Children 18-24 months corrected gestational age are assessed with the Bayley Scales of Infant Development Second Edition to determine neurodevelopmental impairment
5 Year Follow-up MACS-5 Children are assessed using the Child Behaviour Checklist 1 12 - 5 and the Behaviour Rating Inventory of Executive Function Preschool version to determine neurocognitive function
18-24 Month Follow-up Children 18-24 months corrected gestational age are assessed with the Bayley Scales of Infant Development Second Edition to determine neurodevelopmental impairment
5 Year Follow-up MACS-5 Children are assessed using the Child Behaviour Checklist 1 12 - 5 and the Behaviour Rating Inventory of Executive Function Preschool version to determine neurocognitive function
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN72654148 | None | None | None |