Clinical trial NCT00994149: Diazoxide In the Management Of Hypoglycemic Neonates
Official title: Use for Diazoxide in the Initial Management of Hypoglycemia in Infants of Diabetic Mothers and Infants Large for Gestation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Infant, Newborn, Diseases
Pregnancy in Diabetics
Infant, Diabetic Mother
Hypoglycemia
Infant, Large for Gestational Age
Keywords: Infants of Diabetic Mothers
Hypoglycemia
Diazoxide
Large for Gestation Infants
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2009-10-14
Enrollment: 100
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood glucose measurement less than 2.0mmol/L
timeFrame: 14 days
Secondary outcomes:
measure: Number of infants with significantly low blood glucose measurements (<1.5mmol/L).
timeFrame: 14 days
measure: Length of stay for infants in hospital
timeFrame: 14 days
measure: Need for intravenous dextrose infusion to maintain blood glucose above 2.0mmol/L
timeFrame: 14 days
measure: Admission to neonatal intensive care unit (NICU)
timeFrame: 14 days
measure: Thrombocytopenia and/or Leukopenia
timeFrame: 14 days
measure: Electrolyte imbalance requiring clinical intervention (intravenous or oral)
timeFrame: 14 days
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan, Department of Pediatrics, Head of Neonatal Research Group
name: Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M.
role: PRINCIPAL_INVESTIGATOR
References:
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