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The reliability of point-of-care ketone analyser in newborn babies.

An interventional study to determine the reliability of point-of-care ketone analyser in newborn babies within the first 10 postnatal days.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000784415
Acronym
ROCKET
Enrollment
153
Registered
2016-06-16
Start date
2016-07-01
Completion date
2017-04-28
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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, a

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.

Sponsors

Waikato Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
0 to 10 Days
Healthy volunteers
No

Inclusion criteria

Gestational age 35 to 42 completed weeks of gestation Age <= 10 days of age Admitted to the Neonatal Intensive Care Unit

Exclusion criteria

Major congenital anomalies Terminal conditions

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026