Infant, Newborn, Diseases, Pregnancy in Diabetics, Infant, Diabetic Mother, Hypoglycemia, Infant, Large for Gestational Age
Conditions
Keywords
Infants of Diabetic Mothers, Hypoglycemia, Diazoxide, Large for Gestation Infants
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.
Sponsors
University of Saskatchewan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose measurement less than 2.0mmol/L | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Length of stay for infants in hospital | 14 days |
| Need for intravenous dextrose infusion to maintain blood glucose above 2.0mmol/L | 14 days |
| Number of infants with significantly low blood glucose measurements (<1.5mmol/L). | 14 days |
| Thrombocytopenia and/or Leukopenia | 14 days |
| Electrolyte imbalance requiring clinical intervention (intravenous or oral) | 14 days |
| Admission to neonatal intensive care unit (NICU) | 14 days |
Countries
Canada
Contacts
Primary ContactKoravangattu Sankaran, MD, BS, FRCPC, F.C.C.M.
Backup ContactJennifer M Toye, MD, FRCP(C)
Outcome results
None listed