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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01419873
Registration number
NCT01419873
Ethics application status
Date submitted
12/08/2011
Date registered
18/08/2011
Date last updated
29/08/2011
Titles & IDs
Public title
Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
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Scientific title
Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
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Secondary ID [1]
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URA/08/06/039
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hyperglycaemia
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Condition category
Condition code
Metabolic and Endocrine
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Other metabolic disorders
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Reproductive Health and Childbirth
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Childbirth and postnatal care
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Reproductive Health and Childbirth
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Complications of newborn
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Reproductive Health and Childbirth
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0
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Actrapid Human Insulin
Treatment: Drugs: 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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Hypoglycaemia whilst receiving insulin
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Assessment method [1]
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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.
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Timepoint [1]
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Length of hospital stay in NICU which will be from birth to 5 months of age
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Eligibility
Key inclusion criteria
- Birthweight <1500g
- Blood sugar >/= 10mmol/L
- Clinician decision to start an insulin infusion
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Infants who were moribund and not expected to survive
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2011
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Sample size
Target
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Other
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Name
Christchurch Women's Hospital
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01419873
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Adrienne M Lynn, FRACP
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Address
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Canterbury District Helath Board
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01419873
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