Trial | NCT01419873  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    insulin human ...

  • Study Participants

    30
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.
Study Started
Aug 31
2008
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Last Update
Aug 29
2011
Estimate

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

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
No Results Posted