Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04494529
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2020-07-16
Brief Title:
Single Dose Antenatal Corticosteroids SNACS for Women at Risk of Preterm Birth
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Single Dose Antenatal Corticosteroids SNACS Pilot Randomized Control Trial for Women at Risk of Preterm Birth
Status:
COMPLETED
Status Verified Date:
2023-08
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:
SNACS Pilot
Brief Summary:
Antenatal corticosteroids ACS reduce the risks of neonatal death and morbidities such as respiratory distress syndrome in preterm infants
Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone for a total of 24 mg to accelerate fetal lung maturity
We plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose total 12 mg of betamethasone to the standard double dose total 24 mg of betamethasone
The results of this pilot will be combined with the full-scale RCT NCT05114096 for which we have received funding from the Canadian Institutes of Health Research CIHR
Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone for a total of 24 mg to accelerate fetal lung maturity
We plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose total 12 mg of betamethasone to the standard double dose total 24 mg of betamethasone
The results of this pilot will be combined with the full-scale RCT NCT05114096 for which we have received funding from the Canadian Institutes of Health Research CIHR
Detailed Description:
Preterm infants are at risk of mortality and morbidity Antenatal corticosteroids ACS reduce the risks of neonatal death and morbidities such as respiratory distress syndrome
Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone for a total of 24 mg to accelerate fetal lung maturity There are no published clinical trial data on the benefits or risks of a single dose of antenatal corticosteroid vs standard double doses
Pilot trials are now viewed as an almost essential prerequisite to large expensive full scale studies Thus we plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose 12 mg of betamethasone placebo to the standard double dose 12 mg 12 mg of betamethasone as well as the feasibility of the study protocol Secondary outcomes will include process outcomes and pilot clinical outcomes that will be combined with the full-scale RCT for which we have received funding from CIHR
We plan to conduct a 24-month corrected gestational age follow-up which will consist principally of 2 validated parent-filled questionnaires
1 Ages and Stages Questionnaire-3 ASQ
2 Child Behavior Checklist
3 A single question parent report of whether there has been a physician diagnosis of cerebral palsy recommended by our parent partners
Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone for a total of 24 mg to accelerate fetal lung maturity There are no published clinical trial data on the benefits or risks of a single dose of antenatal corticosteroid vs standard double doses
Pilot trials are now viewed as an almost essential prerequisite to large expensive full scale studies Thus we plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose 12 mg of betamethasone placebo to the standard double dose 12 mg 12 mg of betamethasone as well as the feasibility of the study protocol Secondary outcomes will include process outcomes and pilot clinical outcomes that will be combined with the full-scale RCT for which we have received funding from CIHR
We plan to conduct a 24-month corrected gestational age follow-up which will consist principally of 2 validated parent-filled questionnaires
1 Ages and Stages Questionnaire-3 ASQ
2 Child Behavior Checklist
3 A single question parent report of whether there has been a physician diagnosis of cerebral palsy recommended by our parent partners
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None