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Point of Care Ketone Measurement in the Newborn

NCT ID: NCT02341313

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypoglycaemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Newborns at risk of hypoglycaemia

Measurement of ketones

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kathryn Beardsall

OTHER

Sponsor Role lead

Responsible Party

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Kathryn Beardsall

University Lecturer Consultant Neonatologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kathryn Beardsall, MRCP

Role: PRINCIPAL_INVESTIGATOR

Cambridge University

Locations

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addenbrookes Hospital

Cambridge, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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13/EE/0443

Identifier Type: -

Identifier Source: org_study_id

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