HypoglycaemiaPOCKETNCT02341313
Point of Care Ketone Measurement in the Newborn
An observational study of Hypoglycaemia, run by Kathryn Beardsall at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Hypoglycaemia
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: Newborn infants at risk of hypoglycaemia
Who may be able to join
- Infants having blood samples taken for clinical management of glucose control
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Hypoglycaemia
- Keywords
- Hypoglycaemia
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Newborns at risk of hypoglycaemia | Measurement of ketones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of ketone levels between Point of care and laboratory assessment
Measured: Neonatal period up to 28 days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startMar 2014
- Primary completion31 Mar 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kathryn Beardsall
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathryn Beardsall, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Kathryn Beardsall, MRCP, Principal investigator, Cambridge University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341313
- Sponsor's protocol ID
- 13/EE/0443
- Acronym
- Status last verified
- Jan 2019
- First submitted
- 16 Mar 2014
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02341313
- Acronym / sponsor ID
- POCKET / 13/EE/0443
- Conditions
- Hypoglycaemia
- Keywords
- Hypoglycaemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kathryn BeardsallUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborns at risk of hypoglycaemia | – | –Measurement of ketones |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborn infants at risk of hypoglycaemia
Key inclusion criteria (1 listed)
- Infants having blood samples taken for clinical management of glucose control
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure of ketone levels between Point of care and laboratory assessment
Time frame: Neonatal period up to 28 days of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Beardsall, MRCP principal investigator
Cambridge University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoglycaemia, run by Kathryn Beardsall at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of ketone levels between Point of care and laboratory assessment (time frame: Neonatal period up to 28 days of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.