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.
|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|
- 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.
|Study Start Date:||August 2008|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Drug: Actrapid Human Insulin
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419873
|Christchurch Womens Hospital, Canterbury District Health Board|
|Christchurch, New Zealand|
|Principal Investigator:||Adrienne M Lynn, FRACP||Canterbury District Helath Board|