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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adrienne Lynn, Christchurch Women's Hospital
ClinicalTrials.gov Identifier:
NCT01419873
First received: August 12, 2011
Last updated: August 25, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hyperglycaemia
 Drug: Actrapid Human Insulin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Christchurch Women's Hospital:

Primary Outcome Measures:
  • Hypoglycaemia whilst receiving insulin [ Time Frame: Length of hospital stay in NICU which will be from birth to 5 months of age ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 30
Study Start Date: August 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Actrapid Human Insulin
    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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419873

Locations
New Zealand
Christchurch Womens Hospital, Canterbury District Health Board
Christchurch, New Zealand
Sponsors and Collaborators
Christchurch Women's Hospital
Investigators
Principal Investigator: Adrienne M Lynn, FRACP Canterbury District Helath Board
  More Information

No publications provided by Christchurch Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Adrienne Lynn, Dr Adrienne Lynn, Christchurch Women's Hospital
ClinicalTrials.gov Identifier: NCT01419873     History of Changes
Other Study ID Numbers: URA/08/06/039
Study First Received: August 12, 2011
Last Updated: August 25, 2011
Health Authority: New Zealand: Ministry of Health

Keywords provided by Christchurch Women's Hospital:
Hyperglycaemia
Very low birthweight infants
Insulin

Additional relevant MeSH terms:
Birth Weight
Hyperglycemia
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
 Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013