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Diazoxide In the Management Of Hypoglycemic Neonates (DIMOHN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Saskatchewan.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00994149
First received: September 30, 2009
Last updated: October 10, 2009
Last verified: October 2009
History of Changes
  Purpose

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 Intervention Phase
Infant, Newborn, Diseases
Pregnancy in Diabetics
Infant, Diabetic Mother
Hypoglycemia
Infant, Large for Gestational Age
 Drug: Diazoxide
Drug: Ora-plus
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Use for Diazoxide in the Initial Management of Hypoglycemia in Infants of Diabetic Mothers and Infants Large for Gestation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Blood glucose measurement less than 2.0mmol/L [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of infants with significantly low blood glucose measurements (<1.5mmol/L). [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Length of stay for infants in hospital [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Need for intravenous dextrose infusion to maintain blood glucose above 2.0mmol/L [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Admission to neonatal intensive care unit (NICU) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Thrombocytopenia and/or Leukopenia [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Electrolyte imbalance requiring clinical intervention (intravenous or oral) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: October 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Brand Name: Proglycem
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.

  Eligibility

Ages Eligible for Study:   up to 12 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994149

Contacts
Contact: Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M. 1-306-966-8118 k.sankaran@usask.ca
Contact: Jennifer M Toye, MD, FRCP(C) 1-306-966-8118 jtoye13@gmail.com

Locations
Canada, Saskatchewan
Royal University Hospital Not yet recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W4
Contact: Koravangattu Sankaran, MD, FRCPC     1-306-966-8118     k.sankaran@usask.ca    
Contact: Carmen Dmytryshyn, RN     1-306-966-8138        
Principal Investigator: Koravangattu Sankaran, MD, FRCPC            
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
  More Information

Publications:
Hawdon JM. Hypoglycemia and the neonatal brain. Eur J Pediatr 1999;158[Supp1]:S9-12
Nold JL, Georgieff MK. Infants of diabetic mothers. Pediatr Clin N Am 2004;51:619-37
Taketomo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook 14th edition. Hudson (OH): Lexi-comp, Inc. 2007: 485-6
Behrman RE, Kliegman R, Jenson HB, StantonBF. Nelson Textbook of Pediatrics 18th Edition. Philadelphia: WB Saunders Company 2007:783-6

Responsible Party: Dr. Koravangattu Sankaran, University of Saskatchewan, Department of Pediatrics, Neonatal Research Group
ClinicalTrials.gov Identifier: NCT00994149     History of Changes
Other Study ID Numbers: Bio-REB #08-151, HC Control Number: 126963
Study First Received: September 30, 2009
Last Updated: October 10, 2009
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:
Infants of Diabetic Mothers
Hypoglycemia
Diazoxide
Large for Gestation Infants

Additional relevant MeSH terms:
Hypoglycemia
Infant, Newborn, Diseases
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications
 Diazoxide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents

ClinicalTrials.gov processed this record on June 17, 2013