Point of Care Ketone Measurement in the Newborn
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
1 other identifier
observational
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 16, 2014
CompletedFirst Posted
Study publicly available on registry
January 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedJanuary 10, 2019
January 1, 2019
4.1 years
March 16, 2014
January 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of ketone levels between Point of care and laboratory assessment
Neonatal period up to 28 days of age
Study Arms (1)
Newborns at risk of hypoglycaemia
Measurement of ketones
Eligibility Criteria
Newborn infants at risk of hypoglycaemia
You may qualify if:
- Infants having blood samples taken for clinical management of glucose control
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
addenbrookes Hospital
Cambridge, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn Beardsall, MRCP
Cambridge University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- University Lecturer Consultant Neonatologist
Study Record Dates
First Submitted
March 16, 2014
First Posted
January 19, 2015
Study Start
March 1, 2014
Primary Completion
March 31, 2018
Study Completion
August 31, 2018
Last Updated
January 10, 2019
Record last verified: 2019-01