Follow Up Glucose Levels Among Infants of Diabetic Mothers - Full Text View

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00337142

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 I

MedlinePlus related topics: Hypoglycemia

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Retrospective Study

Further study details as provided by Sheba Medical Center:

Estimated Enrollment:	250
Study Start Date:	June 2006

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

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

Contacts

Contact: Ayala Maayan, MD

972-3-530-2451

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator:

Ayala Maayan, MD

Sheba Medical Center

More Information

Study ID Numbers:	SHEBA-06-XXXX-AM-CTIL
Study First Received:	June 13, 2006
Last Updated:	June 13, 2006
ClinicalTrials.gov Identifier:	NCT00337142
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

gestational diabetes
newborn
hypoglycemia

Study placed in the following topic categories:

Diabetes Mellitus
Diabetes, Gestational
Hypoglycemia

ClinicalTrials.gov processed this record on January 16, 2009