DIMOHN: Diazoxide In the Management Of Hypoglycemic Neonates
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Diazoxide Infants in this are will receive 10mg/kg/d of diazoxide divided and given every eight hours |
Drug: Diazoxide
10mg/kg/d divide every 8 hours
Other Names:
|
| Placebo Comparator: Ora-plus Liquid suspension modified to match intervention. Given every eight hours. Provided in shielded syringes. |
Drug: Ora-plus
placebo, give every 8 hours.
|
Outcome Measures
Primary Outcome Measures
- Blood glucose measurement less than 2.0mmol/L [14 days]
Secondary Outcome Measures
- Number of infants with significantly low blood glucose measurements (<1.5mmol/L). [14 days]
- Length of stay for infants in hospital [14 days]
- Need for intravenous dextrose infusion to maintain blood glucose above 2.0mmol/L [14 days]
- Admission to neonatal intensive care unit (NICU) [14 days]
- Thrombocytopenia and/or Leukopenia [14 days]
- Electrolyte imbalance requiring clinical intervention (intravenous or oral) [14 days]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal University Hospital | Saskatoon | Saskatchewan | Canada | S7N 0W4 |
Sponsors and Collaborators
- University of Saskatchewan
Investigators
- Principal Investigator: Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M., University of Saskatchewan, Department of Pediatrics, Head of Neonatal Research Group
Study Documents (Full-Text)
None provided.More Information
Publications
- Agrawal RK, Lui K, Gupta JM. Neonatal hypoglycaemia in infants of diabetic mothers. J Paediatr Child Health. 2000 Aug;36(4):354-6.
- Behrman RE, Kliegman R, Jenson HB, StantonBF. Nelson Textbook of Pediatrics 18th Edition. Philadelphia: WB Saunders Company 2007:783-6
- Cornblath M, Hawdon JM, Williams AF, Aynsley-Green A, Ward-Platt MP, Schwartz R, Kalhan SC. Controversies regarding definition of neonatal hypoglycemia: suggested operational thresholds. Pediatrics. 2000 May;105(5):1141-5. Review.
- Diwakar KK, Sasidhar MV. Plasma glucose levels in term infants who are appropriate size for gestation and exclusively breast fed. Arch Dis Child Fetal Neonatal Ed. 2002 Jul;87(1):F46-8.
- DRASH A, WOLFF F. DRUG THERAPY IN LEUCINE-SENSITIVE HYPOGLYCEMIA. Metabolism. 1964 Jun;13:487-92.
- Dunne MJ, Cosgrove KE, Shepherd RM, Aynsley-Green A, Lindley KJ. Hyperinsulinism in infancy: from basic science to clinical disease. Physiol Rev. 2004 Jan;84(1):239-75. Review.
- Hawdon JM. Hypoglycaemia and the neonatal brain. Eur J Pediatr. 1999 Dec;158 Suppl 1:S9-S12. Review.
- Holtrop PC. The frequency of hypoglycemia in full-term large and small for gestational age newborns. Am J Perinatol. 1993 Mar;10(2):150-4.
- Hoseth E, Joergensen A, Ebbesen F, Moeller M. Blood glucose levels in a population of healthy, breast fed, term infants of appropriate size for gestational age. Arch Dis Child Fetal Neonatal Ed. 2000 Sep;83(2):F117-9.
- McGraw ME, Price DA. Complications of diazoxide in the treatment of nesidioblastosis. Arch Dis Child. 1985 Jan;60(1):62-4.
- Nold JL, Georgieff MK. Infants of diabetic mothers. Pediatr Clin North Am. 2004 Jun;51(3):619-37, viii. Review.
- Screening guidelines for newborns at risk for low blood glucose. Paediatr Child Health. 2004 Dec;9(10):723-740.
- Shirland L. When it is more than transient neonatal hypoglycemia: hyperinsulinemia--a case study challenge. Neonatal Netw. 2001 Jun;20(4):5-11. Review.
- Stenninger E, Flink R, Eriksson B, Sahlèn C. Long-term neurological dysfunction and neonatal hypoglycaemia after diabetic pregnancy. Arch Dis Child Fetal Neonatal Ed. 1998 Nov;79(3):F174-9.
- Stenninger E, Schollin J, Aman J. Early postnatal hypoglycaemia in newborn infants of diabetic mothers. Acta Paediatr. 1997 Dec;86(12):1374-6.
- Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook 14th edition. Hudson (OH): Lexi-comp, Inc. 2007: 485-6
- Touati G, Poggi-Travert F, Ogier de Baulny H, Rahier J, Brunelle F, Nihoul-Fekete C, Czernichow P, Saudubray JM. Long-term treatment of persistent hyperinsulinaemic hypoglycaemia of infancy with diazoxide: a retrospective review of 77 cases and analysis of efficacy-predicting criteria. Eur J Pediatr. 1998 Aug;157(8):628-33.
- Tyrrell VJ, Ambler GR, Yeow WH, Cowell CT, Silink M. Ten years' experience of persistent hyperinsulinaemic hypoglycaemia of infancy. J Paediatr Child Health. 2001 Oct;37(5):483-8.
- Bio-REB #08-151
- HC Control Number: 126963