Diazoxide In the Management Of Hypoglycemic Neonates

Study Overview
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Brief Summary
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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.

Official Title
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Use for Diazoxide in the Initial Management of Hypoglycemia in Infants of Diabetic Mothers and Infants Large for Gestation

Conditions
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Infant, Newborn, Diseases, Pregnancy in Diabetics, Infant, Diabetic Mother, Hypoglycemia, Infant, Large for Gestational Age

Intervention / Treatment
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* Drug: Diazoxide
* Drug: Ora-plus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 12 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diazoxide<br>Infants in this are will receive 10mg/kg/d of diazoxide divided and given every eight hours | Drug: Diazoxide<br>* 10mg/kg/d divide every 8 hours<br>* Other names: Brand Name: Proglycem;|
| Placebo Comparator: Ora-plus<br>Liquid suspension modified to match intervention. Given every eight hours. Provided in shielded syringes. | Drug: Ora-plus<br>* placebo, give every 8 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose measurement less than 2.0mmol/L |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infants with significantly low blood glucose measurements (<1.5mmol/L). |  | 14 days | 
| Length of stay for infants in hospital |  | 14 days | 
| Need for intravenous dextrose infusion to maintain blood glucose above 2.0mmol/L |  | 14 days | 
| Admission to neonatal intensive care unit (NICU) |  | 14 days | 
| Thrombocytopenia and/or Leukopenia |  | 14 days | 
| Electrolyte imbalance requiring clinical intervention (intravenous or oral) |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infants of Diabetic Mothers, Hypoglycemia, Diazoxide, Large for Gestation Infants