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

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

August 12, 2011
August 25, 2011
August 2008
June 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01419873 on Archive Site
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Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates

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.

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Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
New Zealand
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Adrienne Lynn, Christchurch Women's Hospital
Christchurch Women's Hospital
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Principal Investigator: Adrienne M Lynn, FRACP Canterbury District Helath Board
Christchurch Women's Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP