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Follow up Glucose Levels Among Infants of Diabetic Mothers

NCT ID: NCT00337142

Last Updated: 2009-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Newborn Full Term Diabetic Mother

Keywords

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gestational diabetes newborn hypoglycemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Full-term infants, diabetic mothers, Singleton

Exclusion Criteria

* Preterm infants, multiple pregnancy, congenital malformations, clinically ill at birth.
Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Principal Investigators

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Ayala Maayan, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Other Identifiers

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SHEBA-06-4266-AM-CTIL

Identifier Type: -

Identifier Source: org_study_id