The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01419873




Registration number
NCT01419873
Ethics application status
Date submitted
12/08/2011
Date registered
17/08/2011
Date last updated
25/08/2011

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
URA/08/06/039
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
Key inclusion criteria
- Birthweight <1500g

- Blood sugar >/= 10mmol/L

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

Study design
Purpose of the study
Treatment
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
Phase 4
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Primary sponsor type
Other
Name
Christchurch Women's Hospital
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01419873
Trial related presentations / publications
Public notes

Contacts
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