Diazoxide In the Management Of Hypoglycemic Neonates (DIMOHN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00994149
Recruitment Status : Unknown
Verified October 2009 by University of Saskatchewan.
Recruitment status was:  Not yet recruiting
First Posted : October 14, 2009
Last Update Posted : October 14, 2009
Information provided by:
University of Saskatchewan

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
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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : October 2009
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Diazoxide

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 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.

Primary Outcome Measures :
  1. Blood glucose measurement less than 2.0mmol/L [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Number of infants with significantly low blood glucose measurements (<1.5mmol/L). [ Time Frame: 14 days ]
  2. Length of stay for infants in hospital [ Time Frame: 14 days ]
  3. Need for intravenous dextrose infusion to maintain blood glucose above 2.0mmol/L [ Time Frame: 14 days ]
  4. Admission to neonatal intensive care unit (NICU) [ Time Frame: 14 days ]
  5. Thrombocytopenia and/or Leukopenia [ Time Frame: 14 days ]
  6. Electrolyte imbalance requiring clinical intervention (intravenous or oral) [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00994149

Contact: Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M. 1-306-966-8118
Contact: Jennifer M Toye, MD, FRCP(C) 1-306-966-8118

Canada, Saskatchewan
Royal University Hospital Not yet recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W4
Contact: Koravangattu Sankaran, MD, FRCPC    1-306-966-8118   
Contact: Carmen Dmytryshyn, RN    1-306-966-8138      
Principal Investigator: Koravangattu Sankaran, MD, FRCPC         
Sponsors and Collaborators
University of Saskatchewan
Principal Investigator: Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M. University of Saskatchewan, Department of Pediatrics, Head of Neonatal Research Group

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 Identifier: NCT00994149     History of Changes
Other Study ID Numbers: Bio-REB #08-151
HC Control Number: 126963
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Infant, Newborn, Diseases
Fetal Macrosomia
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes, Gestational
Pregnancy Complications
Fetal Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Birth Weight
Body Weight
Signs and Symptoms
Antihypertensive Agents
Vasodilator Agents