Diazoxide In the Management Of Hypoglycemic Neonates

Phase 2

• Conditions: Infant, Newborn, Diseases; Pregnancy in Diabetics; Infant, Diabetic Mother; Hypoglycemia; Infant, Large for Gestational Age
• Interventions: Drug: Ora-plus; Drug: Diazoxide

• Registration Number: NCT00994149
• Lead Sponsor: University of Saskatchewan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-30
• Status Verified: 2009-10
• Study Start: 2009-10
• Study First Submitted QC: 2009-10-10
• Last Update Submitted: 2009-10-10
• Study First Posted: 2009-10-14
• Last Update Posted: 2009-10-14
• Primary Completion: 2011-10
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ora-plus	Ora-plus	Liquid suspension modified to match intervention. Given every eight hours. Provided in shielded syringes.
Diazoxide	Diazoxide	Infants in this are will receive 10mg/kg/d of diazoxide divided and given every eight hours

Primary Outcome Measures

Name	Time	Method
Blood glucose measurement less than 2.0mmol/L	14 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada