Hypoglycemia Clinical Trial
— DIMOHNOfficial title:
Use for Diazoxide in the Initial Management of Hypoglycemia in Infants of Diabetic Mothers and Infants Large for Gestation
Diazoxide is an oral hyperglycemic medication. Diazoxide has been proven effective for treating hypoglycemia in infants and children with some types of persistent hyperinsulinemic hypoglycemia. The mechanism of action results in decreased insulin secretion. One of the causes of hypoglycemia in infants of diabetic mothers occurs due to a transient hyperinsulinemic state postnatally. The investigators have clinical experience and success using diazoxide in their unit for patients with hypoglycemia not adequately managed with intravenous (iv) dextrose and enteral supplementation. In this randomized controlled study the investigators expect that by using diazoxide as the initial treatment for infants of diabetic mothers with asymptomatic hypoglycemia (blood glucose of 2.5 to 2.0mmol/L), the investigators will be able to decrease the number of infants requiring an intravenous by at least thirty percent.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 12 Hours |
Eligibility |
Inclusion Criteria: - Infants of diabetic mothers (IDMs) or infants weighing >90% - Hypoglycemia: two consecutive blood glucose measurements <2.6mol/L and >1.9mmol/L in the first twelve hours of life - > 36 weeks gestational age Exclusion Criteria: - Infants with symptomatic hypoglycemia (regardless of value - Infants who meet criteria for intravenous dextrose according to the Canadian Pediatric Society (CPS) position statement - Infants with contraindications for enteral feeds and/or medications |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Royal University Hospital | Saskatoon | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
University of Saskatchewan |
Canada,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood glucose measurement less than 2.0mmol/L | 14 days | No | |
Secondary | Number of infants with significantly low blood glucose measurements (<1.5mmol/L). | 14 days | Yes | |
Secondary | Length of stay for infants in hospital | 14 days | No | |
Secondary | Need for intravenous dextrose infusion to maintain blood glucose above 2.0mmol/L | 14 days | No | |
Secondary | Admission to neonatal intensive care unit (NICU) | 14 days | Yes | |
Secondary | Thrombocytopenia and/or Leukopenia | 14 days | Yes | |
Secondary | Electrolyte imbalance requiring clinical intervention (intravenous or oral) | 14 days | Yes |
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