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NCT02341313 Clinical Trial

Point of Care Ketone Measurement in the Newborn

Hypoglycaemia Clinical Trial

— POCKET  

Official title:
Feasibility of the Use of Point of Care Technology to Measure Ketone and Lactate Levels in the Newborn at Risk From Hypoglycaemia Due to Impaired Perinatal Counter Regulation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02341313
Other study ID # 13/EE/0443
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2014
Est. completion date August 31, 2018

Study information
Verified date January 2019
Source Cambridge University Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Low blood sugar levels are common in babies after birth. This may be normal as babies can use other sources of energy. However if a baby does not produce these fuels the brain can be starved of energy and be damaged. Measurement of these fuels is not done as part of clinical practice in the newborn. The investigators aim to see whether at the same time as taking the blood sugar level from a heel prick these fuels can be measured in a small drop of blood. At the same time as blood needs to be taken for clinical reasons the study team will to take a drop of blood from 50 babies to see how good the point of care (POC) meters are compared to the laboratory at measuring these fuels. If accurate these POC meters could identifying those at risk from brain damage as well as prevent separation of mothers and babies who are establishing breast feeding.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date August 31, 2018
Est. primary completion date March 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Month
Eligibility Inclusion Criteria:

- Infants having blood samples taken for clinical management of glucose control

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom addenbrookes Hospital Cambridge

Sponsors (1)
Lead Sponsor Collaborator
Kathryn Beardsall

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure of ketone levels between Point of care and laboratory assessment Neonatal period up to 28 days of age
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