Clinical Trial: Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers
Brief Summary:
Thesis Infants of diabetic mothers are at high risk to develop hypoglycemia after birth.
After birth, glucose and ketone bodies are the main substrates of brain energy. Under normal condition, the adrenergic response seen immediately after birth suppresses insulin release and stimulates glucagon secretion which enhances gluconeogenesis and ketogenesis.
An inversion of the insulin/glucagon ratio is seen soon after birth as a normal, physiologic phenomenon. Consequently, a post delivery glucose nadir is reached between 30 to 90 minutes after birth, followed by a spontaneous recovery before 3-4 hours of age.
In infants of diabetic mothers, this inversion of the ratio is postponed and a more profound and sustained hypoglycemia is seen.
Early feeding is of great importance to diminish the severity and incidence of hypoglycemia. But, if despite an appropriate calorie intake, low levels of sugar are seen, an intravenous infusion of glucose should be commenced. In case that IV glucose is not effective or can't be supplied immediately, intramuscular glucagon is a therapeutic alternative.
We hypothesize that a single intramuscular injection of glucagon together with the appropriate oral intake of nutrients is a safe and an effective alternative to the IV infusion of glucose alone in the treatment of hypoglycemia in term infants of diabetic mothers.
Methods Appropriately grown or large for date, term infants of insulin treated diabetic mothers, with no other known medical problems, are potential candidates for our study.
Hypoglycemia will be defined as serum glucose level lower than 45 mg
Detailed Summary:
Sponsor: Shaare Zedek Medical Center
Current Primary Outcome: glucose
Original Primary Outcome:
Current Secondary Outcome: hospitalisation days
Original Secondary Outcome:
Information By: Shaare Zedek Medical Center
Dates:
Date Received: February 11, 2007
Date Started: December 2007
Date Completion:
Last Updated: May 27, 2009
Last Verified: May 2009
