Trials / Unknown
UnknownNCT00994149
Diazoxide In the Management Of Hypoglycemic Neonates
Use for Diazoxide in the Initial Management of Hypoglycemia in Infants of Diabetic Mothers and Infants Large for Gestation
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- University of Saskatchewan · Academic / Other
- Sex
- All
- Age
- 12 Hours
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Diazoxide | 10mg/kg/d divide every 8 hours |
| DRUG | Ora-plus | placebo, give every 8 hours. |
Timeline
- Start date
- 2009-10-01
- Primary completion
- 2011-10-01
- Completion
- 2011-10-01
- First posted
- 2009-10-14
- Last updated
- 2009-10-14
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00994149. Inclusion in this directory is not an endorsement.