Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers
Primary Purpose
Hypoglycemia
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
glucagon
Sponsored by
About this trial
This is an interventional treatment trial for Hypoglycemia focused on measuring hypoglycemia, glucagon, neonatal, gestational diabetes, insulin, glyburide
Eligibility 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%
Sites / Locations
- Share Zedek Medical Center
Outcomes
Primary Outcome Measures
glucose
Secondary Outcome Measures
hospitalisation days
Full Information
NCT ID
NCT00434772
First Posted
February 11, 2007
Last Updated
May 27, 2009
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00434772
Brief Title
Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers
Official Title
Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
5. Study Description
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%. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia
Keywords
hypoglycemia, glucagon, neonatal, gestational diabetes, insulin, glyburide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
glucagon
Primary Outcome Measure Information:
Title
glucose
Secondary Outcome Measure Information:
Title
hospitalisation days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
48 Hours
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bisseliches Myriam, MD
Organizational Affiliation
Shaare Zedek Medical Center - Jerusalem - Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Share Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
12. IPD Sharing Statement
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Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers
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