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Follow up Glucose Levels Among Infants of Diabetic Mothers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00337142
First Posted: June 15, 2006
Last Update Posted: June 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337142


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

Responsible Party: Dr. Ayala Maayan, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00337142     History of Changes
Other Study ID Numbers: SHEBA-06-4266-AM-CTIL
First Submitted: June 13, 2006
First Posted: June 15, 2006
Last Update Posted: June 30, 2009
Last Verified: June 2009

Keywords provided by Sheba Medical Center:
gestational diabetes
newborn
hypoglycemia