Follow up Glucose Levels Among Infants of Diabetic Mothers

Completed

• Conditions: Newborn; Full Term; Diabetic Mother

• Registration Number: NCT00337142
• Lead Sponsor: Sheba Medical Center

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.

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 (1,2,4,6 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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-13
• Study First Submitted QC: 2006-06-13
• Study First Posted: 2006-06-15
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-28
• Last Update Posted: 2009-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Full-term infants, diabetic mothers, Singleton

Exclusion Criteria

• Preterm infants, multiple pregnancy, congenital malformations, clinically ill at birth.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified