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Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates

Primary Purpose

Hyperglycaemia

Status
Completed
Phase
Phase 4
Locations
New Zealand
Study Type
Interventional
Intervention
Actrapid Human Insulin
Sponsored by
Christchurch Women's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycaemia focused on measuring Hyperglycaemia, Very low birthweight infants, Insulin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Birthweight <1500g
  • Blood sugar >/= 10mmol/L
  • Clinician decision to start an insulin infusion

Exclusion Criteria:

  • Infants who were moribund and not expected to survive

Sites / Locations

  • Christchurch Womens Hospital, Canterbury District Health Board

Outcomes

Primary Outcome Measures

Hypoglycaemia whilst receiving insulin
Hypoglycaemia whilst the patient is receiving insulin as per the model-based method will be documented. The patients may require insulin at any time in their admission to NICU from birth to a maximum of 5 months of age when they would no longer be admitted to NICU.

Secondary Outcome Measures

Full Information

First Posted
August 12, 2011
Last Updated
August 25, 2011
Sponsor
Christchurch Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01419873
Brief Title
Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
Official Title
Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Christchurch Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Very low birthweight neonates commonly develop high blood sugar levels. There is an association between high blood sugar levels and poorer short term outcomes but it is not known whether the high sugar level itself actually causes the problems. There are a range of ways to manage high sugar levels but there are no consensus guidelines to follow. One option is to manage the high sugar levels with an infusion of insulin. Studies looking at insulin infusions have often used fixed protocols to guide the amount of insulin to be given and are often complicated by hypoglycaemia. This study investigated whether using a model-based approach to individualise insulin administration to neonates with high sugar levels would provide a safe and effective management option for controlling blood sugar levels and avoid the complication of low blood sugar levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycaemia
Keywords
Hyperglycaemia, Very low birthweight infants, Insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Actrapid Human Insulin
Intervention Description
Actrapid Insulin is a drug used in routine neonatal practice to treat hyperglycaemia. The intervention in this study was to base dosing on insulin by a computer based-model approach as opposed to sliding scales, fixed protocols or clinician intuition
Primary Outcome Measure Information:
Title
Hypoglycaemia whilst receiving insulin
Description
Hypoglycaemia whilst the patient is receiving insulin as per the model-based method will be documented. The patients may require insulin at any time in their admission to NICU from birth to a maximum of 5 months of age when they would no longer be admitted to NICU.
Time Frame
Length of hospital stay in NICU which will be from birth to 5 months of age

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Birthweight <1500g Blood sugar >/= 10mmol/L Clinician decision to start an insulin infusion Exclusion Criteria: Infants who were moribund and not expected to survive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrienne M Lynn, FRACP
Organizational Affiliation
Canterbury District Helath Board
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christchurch Womens Hospital, Canterbury District Health Board
City
Christchurch
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
22871230
Citation
Le Compte AJ, Lynn AM, Lin J, Pretty CG, Shaw GM, Chase JG. Pilot study of a model-based approach to blood glucose control in very-low-birthweight neonates. BMC Pediatr. 2012 Aug 7;12:117. doi: 10.1186/1471-2431-12-117.
Results Reference
derived

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Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates

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