Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
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|ClinicalTrials.gov Identifier: NCT01419873|
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : August 29, 2011
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- 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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01419873
|Christchurch Womens Hospital, Canterbury District Health Board|
|Christchurch, New Zealand|
|Principal Investigator:||Adrienne M Lynn, FRACP||Canterbury District Helath Board|