Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers
Information source: Shaare Zedek Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypoglycemia
Intervention: glucagon (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Shaare Zedek Medical Center Official(s) and/or principal investigator(s):
Bisseliches Myriam, MD, Principal Investigator, Affiliation: Shaare Zedek Medical Center - Jerusalem - Israel
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%. Infants of diabetic
mothers will arrive to the nursery and immediately receive early feeding before 30 minutes
of life. At that time, glucose will be checked. If glucose level is lower than 45 mg%,
treatment with IV glucose or IM glucagon will be initiated. Glucose will be checked every
hour for 4 hours and then every 3 hours (before each meal) for the next 20 hours.
In case blood glucose level is lower than 20 mg% or falls below 45 mg% despite glucagon
treatment, IV glucose will immediately be instituted.
Our aim is to check that IM Glucagon is as good as IV glucose in the treatment of
hypoglycemia in infants of diabetic mothers. We will compare glucose levels after treatment
with IV glucose and IM glucagon, the time till normalization of glucose and full feeding is
achieved and the number of hospitalization days in both groups.
Clinical Details
Official title: Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: glucose
Secondary outcome: hospitalisation days
Eligibility
Minimum age: N/A.
Maximum age: 48 Hours.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- asymptomatic hypoglycemia
- infant of insulin treated diabetic mother
- AGA or LGA
- no other known medical problems
Exclusion Criteria:
- concurrent medical problems
- symptomatic hypoglycemia
- glucose under 20 mg%
Locations and Contacts
Share Zedek Medical Center, Jerusalem 91031, Israel
Additional Information
Starting date: December 2007
Last updated: May 27, 2009
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