Ignite Creation Date:
2024-05-06 @ 3:43 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02351310
Status:
WITHDRAWN
Last Update Posted:
2016-03-14
First Post:
2015-01-27
Brief Title:
Effectiveness of ACS in Extreme Preemies
Sponsor:
Pediatrix
Organization:
Pediatrix
Study Overview
Official Title:
Effects of Antenatal Corticosteroids in Patients With Early 22 - 23w6d Threatened Preterm Birth
Status:
WITHDRAWN
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company decided not to pursue this study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized prospective clinical study that will evaluate the effects of antenatal corticosteroid administration ACS vs placebo in singleton pregnancies who are threatening to deliver prematurely between 22 07 and 23 67 weeks on admission with the goal of improving composite neonatal mortality and morbidity
Detailed Description:
The purpose of this study to evaluate the effects of antenatal corticosteroid administration ACS vs placebo in patients who are threatening to deliver prematurely with well-established gestational ages between 22 07 and 23 67 weeks at the time of admission If the delivery can be safely delayed at least 3 hours and there is no contraindication to steroid administration the patient is eligible to be randomized Randomization will be blinded to the patient and the staff caring for the patient and will be stratified by gestational age those at 22 07 to 22 67 weeks and those at 23 07 weeks to 23 67 weeks Randomized patients will be assignment to either active drug or placebo at the doses and frequencies below
2 doses of Betamethasone 12 mg intramuscularly IM 24 hours apart or if as in some hospitals occasionally occurs and betamethasone is unavailable -
4 doses of Dexamethasone IM 6 mg 12 hours apart
Remainder of care will be at the discretion of the clinician
Randomized 22 07 - 22 67
For patients randomized between 22 07 and 22 67 weeks and who are undelivered 24 07 weeks the decision as to whether to administer an additional course or courses of ACS will also be at the discretion of the clinician
Randomized 23 07 to 23 67
For those patients randomized at 23 07 to 23 67 weeks and who remain undelivered 24 07 weeks and 1 week after study medication was administered a second blinded set of medicationsplacebos will be provided For patients who received Betamethasone or dexamethasone placebo will be provided and for those who received placebo Betamethasone will be providedfor both at the doses described in 343 In this group at any time 24 07 weeks and less than one week of the previous dose if the clinician feels the patient is still at risk for delivering this second blinded set of study drugs will be administered This will allow the patient to receive at least one actual course of ACS if undelivered at 24w0d In this group if the patient remains undelivered at 25 weeks administration of an open label course of ACS will be at the discretion of the MD
Primary Outcome of this study is composite morbidity and mortality The N on this study is 68 34 in each group
2 doses of Betamethasone 12 mg intramuscularly IM 24 hours apart or if as in some hospitals occasionally occurs and betamethasone is unavailable -
4 doses of Dexamethasone IM 6 mg 12 hours apart
Remainder of care will be at the discretion of the clinician
Randomized 22 07 - 22 67
For patients randomized between 22 07 and 22 67 weeks and who are undelivered 24 07 weeks the decision as to whether to administer an additional course or courses of ACS will also be at the discretion of the clinician
Randomized 23 07 to 23 67
For those patients randomized at 23 07 to 23 67 weeks and who remain undelivered 24 07 weeks and 1 week after study medication was administered a second blinded set of medicationsplacebos will be provided For patients who received Betamethasone or dexamethasone placebo will be provided and for those who received placebo Betamethasone will be providedfor both at the doses described in 343 In this group at any time 24 07 weeks and less than one week of the previous dose if the clinician feels the patient is still at risk for delivering this second blinded set of study drugs will be administered This will allow the patient to receive at least one actual course of ACS if undelivered at 24w0d In this group if the patient remains undelivered at 25 weeks administration of an open label course of ACS will be at the discretion of the MD
Primary Outcome of this study is composite morbidity and mortality The N on this study is 68 34 in each group
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