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Trial registered on ANZCTR


Registration number
ACTRN12616000784415
Ethics application status
Approved
Date submitted
13/06/2016
Date registered
16/06/2016
Date last updated
20/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The reliability of point-of-care ketone analyser in newborn babies.
Scientific title
An interventional study to determine the reliability of point-of-care ketone analyser in newborn babies within the first 10 postnatal days.
Secondary ID [1] 289425 0
nil known
Universal Trial Number (UTN)
U1111-1184-2481
Trial acronym
ROCKET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Babies in the NICU for any reason, if gestation >= 35 weeks and age < 10 days 299100 0
Condition category
Condition code
Metabolic and Endocrine 299131 299131 0 0
Metabolic disorders
Reproductive Health and Childbirth 299143 299143 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will measure a ketone (betahydroxybutyrate) on a point of care analyser ("Statstrip", Nova biochemical) and by standard laboratory method. The Statstrip requires a single drop of blood and the result is available in 10 seconds. The Statstrip and the lab samples will be taken simultaneously and the results will be compared. The results will be available to the treating clinicians.
The subjects will be newborn infants in the first 10 days of life, admitted to the neonatal intensive care unit, and requiring blood tests for clinical purposes.
Each subject will be assessed once only.
Intervention code [1] 295014 0
Diagnosis / Prognosis
Comparator / control treatment
The control sample will be the laboratory sample, taken at the same time as the statstrip sample as an additional 0.4 ml whilst sampling for other purposes. The analysis will occur in the hospital laboratory located on the same hospital site. The testing technique in the laboratory will use a Roche Cobas 6000 analyser on the 501 module.
Control group
Active

Outcomes
Primary outcome [1] 298603 0
To determine in preterm and term babies in the first ten days of life the level of agreement in the measured blood glucose concentrations of betahydroxybutyrate between the point of care analyser and the laboratory analysis
Timepoint [1] 298603 0
The first 10 days of life
Secondary outcome [1] 324699 0
To determine if the measured accuracy is influenced by the concentrations of betahydroxybutyrate. This will be assessed using the difference between the two sampling methods, and applying this difference to the mean concentration (ie the midpoint between the two samples). This is viewed and analysed as a Bland-Altman plot.
Timepoint [1] 324699 0
The first 10 days of life
Secondary outcome [2] 324700 0
To determine the range of blood concentrations of betahydroxybutyrate. It is expected that the lower end of the range will be 0.0 mmol/l, but the upper end of the range is unknown. The range may reflect one or other or both methods, or the midpoints of each baby's measurement, depending on what is found from primary outcome 1.
Timepoint [2] 324700 0
The first 10 days of life
Secondary outcome [3] 324701 0
To determine if age, sex, feeding, and reason for admission are related to the blood concentrations of betahydroxybutyrate. These variables will be prospectively gathered at the time of each enrolment , and retained in paper form and on computer as the study progresses. The blood glucose concentrations of betahydroxybutyrate will reflect one or other or both methods, or the midpoints of each baby's measurement, depending on what is found from primary outcome 1.
Timepoint [3] 324701 0
The first 10 days of life
Secondary outcome [4] 324796 0
To determine the variability of blood concentrations of betahydroxybutyrate. It is expected that the data will cluster at the lower end of the range, but the distribution will be assessed by histogram evaluation. The variability will reflect measurements from one or other or both methods, or the midpoints of each baby's measurement, depending on what is found from primary outcome 1.
Timepoint [4] 324796 0
The first 10 days of life

Eligibility
Key inclusion criteria
Gestational age 35 to 42 completed weeks of gestation
Age <= 10 days of age
Admitted to the Neonatal Intensive Care Unit
Minimum age
0 Days
Maximum age
10 Days
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major congenital anomalies
Terminal conditions

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Categorical variables will be analysed using number and percent. Continuous variables will be analysed to determine the distribution, range, and variance and compared by Students t test or the Mann-Whitney U test.
Bland-Altman plots will be used to compare the two methods of analysis.
Relationships between demographic and clinical variables and ketone concentrations will be explored using regression analyses.

Power and Sample size :
Annually, approximately 600 babies of greater than or equal to 35 weeks gestation are admitted to the Waikato Newborn Intensive Care Unit. Of these, at least 450 babies (75%) will require a blood test. We plan to have the blood test for the study taken at the same time as routine blood samples are taken.

Our major aim is to test the reliability of the point-of-care analyser with the gold standard laboratory analyser. Normal blood ketone concentrations are reported to vary over the newborn period, ranging from approximately 0.01 - 0.43 mmol/L (SD approximately 0.1mmol/L) increasing on days 2 to 3 and then decreasing. In a deprived population of term babies (n= 578) in Nepal, blood concentrations of beta hydroxybutyrate in the first 48 hours after birth were reported to be 0.00 -1.34 mmol/L, with a geometric mean (SD) of 0.11 (.004) mmol/L.

Brain ketone uptake is proportional to circulating concentrations. It has been estimated that beta-hydroxybutyrate might contribute 12-13% of cerebral energy requirements at mean arterial concentrations of 0.16 - 0.28 mmol/L6. Thus measurement of ketone concentrations to accuracy of < 0.05 mmol/L is likely to be clinically meaningful.

In order to have a 95% level of confidence to detect the mean blood ketone concentration to a precision of agreement equivalent to a SD 0.2420, we would need to recruit 200 babies.

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 7950 0
New Zealand
State/province [1] 7950 0

Funding & Sponsors
Funding source category [1] 293796 0
Charities/Societies/Foundations
Name [1] 293796 0
Waikato Medical Research Foundation
Address [1] 293796 0
Waikato Hospital
Pembroke St
Hamilton
New Zealand 3204
Country [1] 293796 0
New Zealand
Primary sponsor type
Hospital
Name
Waikato Hospital
Address
Waikato Hospital
Pembroke St
Hamilton
New Zealand 3204
Country
New Zealand
Secondary sponsor category [1] 292634 0
None
Name [1] 292634 0
Address [1] 292634 0
Country [1] 292634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295234 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 295234 0
Ministry of Health
Freyberg Building
20 Aitken St
PO Box 5013
Wellington 6011
Ethics committee country [1] 295234 0
New Zealand
Date submitted for ethics approval [1] 295234 0
03/05/2016
Approval date [1] 295234 0
30/05/2016
Ethics approval number [1] 295234 0
16 /NT A/ 67

Summary
Brief summary
Low blood sugar levels are common in babies after birth. Exclusively breast fed babies have been shown to have lower blood concentrations of glucose and higher concentrations of ketones than babies who receive formula milk. Ketones may provide a source of fuel for energy, particularly for the brain, when glucose concentrations are low. However if a baby does not produce ketones the brain can be starved of energy and be damaged. Measurement of blood ketone concentrations is not routinely done as part of clinical practice.

We aim to see whether we can reliably measure ketones in a small drop of blood. We will measure ketones on a point-of-care analyser as well as in the laboratory, using the gold standard analysis and compare the results. The blood test will be taken at the same time as routine blood samples are being taken. If the point-of-care analyser can help identify accurately those at risk of brain damage when glucose concentrations are low, this may help to prevent separation of mothers and babies as breast-feeding is being established.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66634 0
Dr Deborah Harris
Address 66634 0
Neonatal Intensive Care Unit
Waikato Hospital
Pembroke St
Hamilton
New Zealand 3204
Country 66634 0
New Zealand
Phone 66634 0
+6421471790
Fax 66634 0
Email 66634 0
deborah.harris@waikatodhb.health.nz
Contact person for public queries
Name 66635 0
Dr Deborah Harris
Address 66635 0
Neonatal Intensive Care Unit
Waikato Hospital
Pembroke St
Hamilton
New Zealand 3204
Country 66635 0
New Zealand
Phone 66635 0
+6421471790
Fax 66635 0
Email 66635 0
deborah.harris@waikatodhb.health.nz
Contact person for scientific queries
Name 66636 0
Dr Deborah Harris
Address 66636 0
Neonatal Intensive Care Unit
Waikato Hospital
Pembroke St
Hamilton
New Zealand 3204
Country 66636 0
Angola
Phone 66636 0
+6421471790
Fax 66636 0
Email 66636 0
deborah.harris@waikatodhb.health.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary