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Diazoxide In the Management Of Hypoglycemic Neonates (DIMOHN)

Primary Purpose

Infant, Newborn, Diseases, Pregnancy in Diabetics, Infant, Diabetic Mother

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Diazoxide
Ora-plus
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Newborn, Diseases focused on measuring Infants of Diabetic Mothers, Hypoglycemia, Diazoxide, Large for Gestation Infants

Eligibility Criteria

undefined - 12 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Diazoxide

Ora-plus

Arm Description

Infants in this are will receive 10mg/kg/d of diazoxide divided and given every eight hours

Liquid suspension modified to match intervention. Given every eight hours. Provided in shielded syringes.

Outcomes

Primary Outcome Measures

Blood glucose measurement less than 2.0mmol/L

Secondary Outcome Measures

Number of infants with significantly low blood glucose measurements (<1.5mmol/L).
Length of stay for infants in hospital
Need for intravenous dextrose infusion to maintain blood glucose above 2.0mmol/L
Admission to neonatal intensive care unit (NICU)
Thrombocytopenia and/or Leukopenia
Electrolyte imbalance requiring clinical intervention (intravenous or oral)

Full Information

First Posted
September 30, 2009
Last Updated
October 10, 2009
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT00994149
Brief Title
Diazoxide In the Management Of Hypoglycemic Neonates
Acronym
DIMOHN
Official Title
Use for Diazoxide in the Initial Management of Hypoglycemia in Infants of Diabetic Mothers and Infants Large for Gestation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Saskatchewan

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Newborn, Diseases, Pregnancy in Diabetics, Infant, Diabetic Mother, Hypoglycemia, Infant, Large for Gestational Age
Keywords
Infants of Diabetic Mothers, Hypoglycemia, Diazoxide, Large for Gestation Infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diazoxide
Arm Type
Experimental
Arm Description
Infants in this are will receive 10mg/kg/d of diazoxide divided and given every eight hours
Arm Title
Ora-plus
Arm Type
Placebo Comparator
Arm Description
Liquid suspension modified to match intervention. Given every eight hours. Provided in shielded syringes.
Intervention Type
Drug
Intervention Name(s)
Diazoxide
Other Intervention Name(s)
Brand Name: Proglycem
Intervention Description
10mg/kg/d divide every 8 hours
Intervention Type
Drug
Intervention Name(s)
Ora-plus
Intervention Description
placebo, give every 8 hours.
Primary Outcome Measure Information:
Title
Blood glucose measurement less than 2.0mmol/L
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Number of infants with significantly low blood glucose measurements (<1.5mmol/L).
Time Frame
14 days
Title
Length of stay for infants in hospital
Time Frame
14 days
Title
Need for intravenous dextrose infusion to maintain blood glucose above 2.0mmol/L
Time Frame
14 days
Title
Admission to neonatal intensive care unit (NICU)
Time Frame
14 days
Title
Thrombocytopenia and/or Leukopenia
Time Frame
14 days
Title
Electrolyte imbalance requiring clinical intervention (intravenous or oral)
Time Frame
14 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Hours
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M.
Phone
1-306-966-8118
Email
k.sankaran@usask.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer M Toye, MD, FRCP(C)
Phone
1-306-966-8118
Email
jtoye13@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koravangattu Sankaran, MD, BS, FRCPC, F.C.C.M.
Organizational Affiliation
University of Saskatchewan, Department of Pediatrics, Head of Neonatal Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W4
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koravangattu Sankaran, MD, FRCPC
Phone
1-306-966-8118
Email
k.sankaran@usask.ca
First Name & Middle Initial & Last Name & Degree
Carmen Dmytryshyn, RN
Phone
1-306-966-8138
First Name & Middle Initial & Last Name & Degree
Koravangattu Sankaran, MD, FRCPC

12. IPD Sharing Statement

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Diazoxide In the Management Of Hypoglycemic Neonates

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