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Follow up Glucose Levels Among Infants of Diabetic Mothers

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00337142
First received: June 13, 2006
Last updated: June 28, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Phase
Newborn
Full Term
Diabetic Mother
 Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:

MedlinePlus related topics: Hypoglycemia
U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 250
Study Start Date: June 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • Full-term infants, diabetic mothers, Singleton

Exclusion Criteria:

  • Preterm infants, multiple pregnancy, congenital malformations, clinically ill at birth.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337142

Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ayala Maayan, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Ayala Maayan, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00337142     History of Changes
Other Study ID Numbers: SHEBA-06-4266-AM-CTIL
Study First Received: June 13, 2006
Last Updated: June 28, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
gestational diabetes
newborn
hypoglycemia

ClinicalTrials.gov processed this record on May 23, 2013