Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04869709
Status:
UNKNOWN
Last Update Posted:
2021-05-03
First Post:
2021-04-09
Brief Title:
Late Preterm Corticosteroids and Neonatal Hypoglycemia
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Timing of Late Preterm Corticosteroid Administration and Neonatal Hypoglycemia
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_RECRUITING
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:
This is a prospective randomized controlled trial investigating the timing of betamethasone administration in late preterm infants in relation to delivery and impact on neonatal hypoglycemia Previous data has shown that neonatal hypoglycemia is increased in late preterm infants that were exposed to antenatal corticosteroids The investigators hypothesize that the timing of steroid administration may impact the development of neonatal hypoglycemia
Detailed Description:
The use of antenatal corticosteroids for women at risk for preterm delivery has become widely adopted as standard of care The American College of Obstetrics and Gynecologists ACOG officially recommends the use of corticosteroids for pregnant women between 24 and 34 weeks of gestation at risk of delivery within 7 days Since publication of the ALPS trial the Society of Maternal Fetal Medicine SMFM published guidelines supporting the use of late preterm steroids for singleton pregnancies between 34 weeks 0 days and 36 weeks 6 days who are at high risk of preterm birth within 7 days
A secondary finding of the ALPS trial included the observation that the administration of antenatal betamethasone significantly increased the rate of neonatal hypoglycemia the authors emphasized that while the long-term risks associated with neonatal hypoglycemia are not fully known significant hypoglycemia is associated with poor neurodevelopmental outcome
The optimal interval for administering late preterm steroids before delivery to minimize the risks of hypoglycemia while maximizing the benefits of fetal lung maturity has not been identified The proposed research study will further investigate this question by randomizing patients to receive late preterm corticosteroids 2 days before delivery versus 7 days before delivery in order to determine if the rates and severity of neonatal hypoglycemia are different
A secondary finding of the ALPS trial included the observation that the administration of antenatal betamethasone significantly increased the rate of neonatal hypoglycemia the authors emphasized that while the long-term risks associated with neonatal hypoglycemia are not fully known significant hypoglycemia is associated with poor neurodevelopmental outcome
The optimal interval for administering late preterm steroids before delivery to minimize the risks of hypoglycemia while maximizing the benefits of fetal lung maturity has not been identified The proposed research study will further investigate this question by randomizing patients to receive late preterm corticosteroids 2 days before delivery versus 7 days before delivery in order to determine if the rates and severity of neonatal hypoglycemia are different
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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