- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01419873
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Christchurch, New Zealand
- Christchurch Womens Hospital, Canterbury District Health Board
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Length of hospital stay in NICU which will be from birth to 5 months of age
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adrienne M Lynn, FRACP, Canterbury District Helath Board
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- URA/08/06/039
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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