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Diazoxide In the Management Of Hypoglycemic Neonates

NCT00994149 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-10-14

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Diazoxide

10mg/kg/d divide every 8 hours

DRUG

Ora-plus

placebo, give every 8 hours.

Sponsors & Collaborators

  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M. · University of Saskatchewan, Department of Pediatrics, Head of Neonatal Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
12 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00994149 on ClinicalTrials.gov