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Infant, Newborn, Diseases | Diazoxide In the Management Of Hypoglycemic Neonates

Infant, Newborn, Diseases research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Infant, Newborn, Diseases

Pregnancy in Diabetics

Infant, Diabetic Mother

Hypoglycemia

Infant, Large for Gestational Age

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Diazoxide10mg/kg/d divide every 8 hours

Drug:Ora-plusplacebo, give every 8 hours.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Ora-plusLiquid suspension modified to match intervention. Given every eight hours. Provided in shielded syringes.

Study Status

Unknown status

Start Date: October 2009

Completed Date: October 2011

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Blood glucose measurement less than 2.0mmol/L

Secondary Outcome: Number of infants with significantly low blood glucose measurements (<1.5mmol/L).

Study sponsors, principal investigator, and references

Principal Investigator: Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M.

Lead Sponsor: University of Saskatchewan

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00994149

Screening guidelines for newborns at risk for low blood glucose. Paediatr Child Health. 2004 Dec;9(10):723-740. English, French, English.

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