Hypoxic-Ischemic EncephalopathyMeCoolNCT06932354
Metabolic Monitoring During Therapeutic Hypothermia (Cooling) for Hypoxic Ischaemic Encephalopathy
A study testing CGM in people with Hypoxic-Ischemic Encephalopathy, run by Kathryn Beardsall at 1 site in United Kingdom.
Trial summary
This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies. Read more about this study
- Who is it for?
- Ages Up to 2 days
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy
- What is being tested?
- CGM
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2019to 31 Dec 2024
- Phase
- Interventional
- 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 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hypoxic ischaemic encephalopathy Informed parental consent
Who cannot join
- Known significant congenital malformation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Addenbrookes Hospital Trust
Cambridge, cambridge, CB2 0QQ
About this study
This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.
Read the detailed description
In the UK approximately 1200 babies per year undergo 'cooling' for the treatment of 'birth asphyxia' or hypoxic ischaemic encephalopathy (HIE). HIE not only impacts on brain metabolism but disturbs the normal metabolic balance in these babies who are at risk of hypoglycaemia and hyperglycaemia, which may exacerbate the effect of their primary brain injury. The clinical significance of hypoglycaemia is dependent on the availability of alternative fuels such as ketones and lactate. Clinical management of glucose control in these extremely ill babies is challenging because of infrequent blood glucose measurements and inability to measure alternative fuels. We have used continuous glucose monitoring (CGM) to help target glucose control in extremely preterm infants who require intensive care. CGM however has not been used in babies who are being cooled. This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Being tested
- CGM
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMDevice
masked continuous glucose monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of time glucose levels measured on CGM are in target
Percent Time in target (2.6-10mmol/l)
Measured: From sensor insertion for up to the first 7 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start10 May 2019
- Primary completion1 Dec 2022
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932354
- Sponsor's protocol ID
- 251956
- Acronym
- MeCool
- Status last verified
- Apr 2025
- First submitted
- 26 Jan 2021
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Monitoring During Therapeutic Hypothermia (Cooling) for Hypoxic Ischaemic Encephalopathy
- ClinicalTrials.gov ID
- NCT06932354
- Acronym / sponsor ID
- MeCool / 251956
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kathryn BeardsallUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Apr 2025 (actual)
- 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.
This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.
Detailed description
In the UK approximately 1200 babies per year undergo 'cooling' for the treatment of 'birth asphyxia' or hypoxic ischaemic encephalopathy (HIE). HIE not only impacts on brain metabolism but disturbs the normal metabolic balance in these babies who are at risk of hypoglycaemia and hyperglycaemia, which may exacerbate the effect of their primary brain injury. The clinical significance of hypoglycaemia is dependent on the availability of alternative fuels such as ketones and lactate. Clinical management of glucose control in these extremely ill babies is challenging because of infrequent blood glucose measurements and inability to measure alternative fuels. We have used continuous glucose monitoring (CGM) to help target glucose control in extremely preterm infants who require intensive care. CGM however has not been used in babies who are being cooled. This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Hypoxic ischaemic encephalopathy Informed parental consent
Key exclusion criteria (1 listed)
- Known significant congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGMmasked continuous glucose monitoring | Device | – |
Primary outcome
Percent of time glucose levels measured on CGM are in target
Time frame: From sensor insertion for up to the first 7 days of life
Percent Time in target (2.6-10mmol/l)
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 17 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Hypoxic-Ischemic Encephalopathy
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM in people with Hypoxic-Ischemic Encephalopathy, 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 17 Apr 2025. 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?
Percent of time glucose levels measured on CGM are in target (time frame: From sensor insertion for up to the first 7 days of life). 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 17 Apr 2025.