Diazoxide In the Management Of Hypoglycemic Neonates (DIMOHN)

University of Saskatchewan

Status and phase: Unknown; Phase 3; Phase 2

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

Treatments: Drug: Ora-plus; Drug: Diazoxide

Study type: Interventional

Funder types: Other

Identifiers

NCT00994149

Bio-REB #08-151

HC Control Number: 126963

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 12 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Diazoxide

Experimental group

Description:

Infants in this are will receive 10mg/kg/d of diazoxide divided and given every eight hours

Treatment:

Drug: Diazoxide

Ora-plus

Placebo Comparator group

Description:

Liquid suspension modified to match intervention. Given every eight hours. Provided in shielded syringes.

Treatment:

Drug: Ora-plus