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NCT00337142 Clinical Trial

Follow up Glucose Levels Among Infants of Diabetic Mothers

Newborn Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00337142
Other study ID # SHEBA-06-4266-AM-CTIL
Secondary ID
Status Completed
Phase Phase 1
First received June 13, 2006
Last updated June 28, 2009
Start date June 2006
Est. completion date December 2006

Study information
Verified date June 2009
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Day
Eligibility Inclusion Criteria:

- Full-term infants, diabetic mothers, Singleton

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center
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