Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
- Conditions
- Hyperglycaemia
- Registration Number
- NCT01419873
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Birthweight <1500g
- Blood sugar >/= 10mmol/L
- Clinician decision to start an insulin infusion
- Infants who were moribund and not expected to survive
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Hypoglycaemia whilst receiving insulin 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Christchurch Womens Hospital, Canterbury District Health Board
🇳🇿Christchurch, New Zealand