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

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: NCT01419873
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : August 29, 2011
Information provided by (Responsible Party):
Adrienne Lynn, Christchurch Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Hyperglycaemia Drug: Actrapid Human Insulin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
Study Start Date : August 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01419873

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Adrienne Lynn, Dr Adrienne Lynn, Christchurch Women's Hospital Identifier: NCT01419873     History of Changes
Other Study ID Numbers: URA/08/06/039
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: August 29, 2011
Last Verified: August 2011
Keywords provided by Adrienne Lynn, Christchurch Women's Hospital:
Very low birthweight infants
Additional relevant MeSH terms:
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Birth Weight
Glucose Metabolism Disorders
Metabolic Diseases
Body Weight
Signs and Symptoms
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs