Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337142
Status:
COMPLETED
Last Update Posted:
2009-06-30
First Post:
2006-06-13
Brief Title:
Follow up Glucose Levels Among Infants of Diabetic Mothers
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-06
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:
Infants to diabetic mothers IDM are at risk for developing hypoglycemia after birth Glucose level follow ups are recommended to each IDM However there are no recommendations as to how long this follow up should be performed for nor are there safe glucose levels that allow stopping glucose monitoring
The aim of the study is to retrospectively follow up glucose levels among IDMs in order to find risk factors for developing hypoglycemia and determine time and glucose levels that would permit monitoring cessation
The aim of the study is to retrospectively follow up glucose levels among IDMs in order to find risk factors for developing hypoglycemia and determine time and glucose levels that would permit monitoring cessation
Detailed Description:
A retrospective study of 250-300 IDMs born in a single large medical center Data will be collected as follows Gestational age birth weight sex delivery mode type of maternal diabetes other maternal diseases feeding mode Glucose levels as were recorded according to newborn protocol 1246 hours after delivery and then every 8 hours for total of 48 hours Data of hypoglycemia treatment if given will be collected
Later we will statistically try to determine the risk factors for developing hypoglycemia and the safe time and glucose levels to stop monitoring
Later we will statistically try to determine the risk factors for developing hypoglycemia and the safe time and glucose levels to stop monitoring
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