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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
Scientific title
Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperglycaemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Study type
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Hypoglycaemia whilst receiving insulin - 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.
Timepoint [1] 0 0
Length of hospital stay in NICU which will be from birth to 5 months of age

Key inclusion criteria
- Birthweight <1500g

- Blood sugar >/= 10mmol/L

- Clinician decision to start an insulin infusion
Minimum age
No limit
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Infants who were moribund and not expected to survive

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0

Funding & Sponsors
Primary sponsor type
Christchurch Women's Hospital

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Adrienne M Lynn, FRACP
Address 0 0
Canterbury District Helath Board
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications