Diazoxide In the Management Of Hypoglycemic Neonates

Hypoglycemia Clinical Trial

— DIMOHN  

Official title:

Use for Diazoxide in the Initial Management of Hypoglycemia in Infants of Diabetic Mothers and Infants Large for Gestation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00994149
• Other study ID #: Bio-REB #08-151
• Secondary ID: HC Control Numbe
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: September 30, 2009
• Last updated: October 10, 2009
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: October 2009
• Source: University of Saskatchewan
• Contact: Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M.
• Phone: 1-306-966-8118
• Email: k.sankaran[@]usask.ca
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Macrosomia
• Hypoglycemia
• Infant, Diabetic Mother
• Infant, Large for Gestational Age
• Infant, Newborn, Diseases
• Pregnancy in Diabetics

Intervention

Drug:
• Diazoxide
10mg/kg/d divide every 8 hours
• Ora-plus
placebo, give every 8 hours.

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

References & Publications (18)

Agrawal RK, Lui K, Gupta JM. Neonatal hypoglycaemia in infants of diabetic mothers. J Paediatr Child Health. 2000 Aug;36(4):354-6. — View Citation

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. — View Citation

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. — View Citation

DRASH A, WOLFF F. DRUG THERAPY IN LEUCINE-SENSITIVE HYPOGLYCEMIA. Metabolism. 1964 Jun;13:487-92. — View Citation

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. — View Citation

Hawdon JM. Hypoglycaemia and the neonatal brain. Eur J Pediatr. 1999 Dec;158 Suppl 1:S9-S12. Review. — View Citation

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. — View Citation

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. — View Citation

McGraw ME, Price DA. Complications of diazoxide in the treatment of nesidioblastosis. Arch Dis Child. 1985 Jan;60(1):62-4. — View Citation

Nold JL, Georgieff MK. Infants of diabetic mothers. Pediatr Clin North Am. 2004 Jun;51(3):619-37, viii. Review. — View Citation

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

Shirland L. When it is more than transient neonatal hypoglycemia: hyperinsulinemia--a case study challenge. Neonatal Netw. 2001 Jun;20(4):5-11. Review. — View Citation

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. — View Citation

Stenninger E, Schollin J, Aman J. Early postnatal hypoglycaemia in newborn infants of diabetic mothers. Acta Paediatr. 1997 Dec;86(12):1374-6. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose measurement less than 2.0mmol/L		14 days	No
Secondary	Number of infants with significantly low blood glucose measurements (<1.5mmol/L).		14 days	Yes
Secondary	Length of stay for infants in hospital		14 days	No
Secondary	Need for intravenous dextrose infusion to maintain blood glucose above 2.0mmol/L		14 days	No
Secondary	Admission to neonatal intensive care unit (NICU)		14 days	Yes
Secondary	Thrombocytopenia and/or Leukopenia		14 days	Yes
Secondary	Electrolyte imbalance requiring clinical intervention (intravenous or oral)		14 days	Yes