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

June 13, 2006
June 28, 2009
June 2006
December 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00337142 on ClinicalTrials.gov Archive Site
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Follow up Glucose Levels Among Infants of Diabetic Mothers
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

primary care clinic

  • Newborn
  • Full Term
  • Diabetic Mother
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
December 2006
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Full-term infants, diabetic mothers, Singleton

Exclusion Criteria:

  • Preterm infants, multiple pregnancy, congenital malformations, clinically ill at birth.
Both
up to 1 Day
No
Contact information is only displayed when the study is recruiting subjects
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NCT00337142
SHEBA-06-4266-AM-CTIL
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Dr. Ayala Maayan, Sheba Medical Center
Sheba Medical Center
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Principal Investigator: Ayala Maayan, MD Sheba Medical Center
Sheba Medical Center
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP