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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00994149
Other study ID # Bio-REB #08-151
Secondary ID HC Control Numbe
Status Not yet recruiting
Phase Phase 2/Phase 3
First received September 30, 2009
Last updated October 10, 2009
Start date October 2009
Est. completion date October 2011

Study information

Verified date October 2009
Source University of Saskatchewan
Contact Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M.
Phone 1-306-966-8118
Email k.sankaran@usask.ca
Is FDA regulated No
Health authority Canada: Health CanadaCanada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Diazoxide
10mg/kg/d divide every 8 hours
Ora-plus
placebo, give every 8 hours.

Locations

Country Name City State
Canada Royal University Hospital Saskatoon Saskatchewan

Sponsors (1)

Lead Sponsor Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

References & Publications (18)

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Outcome

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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