Status EpilepticusCAPTURENCT05259891
eegCap Application in Paediatrics wiTh redUced GCS in REsus
An observational study of Status Epilepticus and Altered Level of Consciousness, run by University College Cork at 1 site in Ireland.
Trial summary
Children frequently present with altered or reduced consciousness levels to emergency departments. By using EEG monitoring, subclinical seizure activity may be detected, leading to earlier pharmacological intervention and improved outcomes. Read more about this study
- Who is it for?
- Ages 0 to 176 months
- Conditions the study is for
- Status Epilepticus, Altered Level of Consciousness, Non-epileptic Seizures
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 5 Jul 2021to 20 Jun 2022
- 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 0 to 176 months
- All sexes
- Child
Study population: The study population is all children between 0 years and 15 years and 11 months who present to the Resuscitation room of the Emergency Department of Cork University Hospital. Children can have underlying co-morbidities ( eg neurodisability, epilepsy) or be their first time presenting to a hospital.
Who may be able to join
- Children between 0 and 15 years and 11 months who present to Resuscitation Room, ED, CUH with a Glasgow Coma Scale (GCS) < 11 or, a reduction in baseline GCS in the case of children with significant neurodisability at baseline
Who cannot join
- Polytrauma
- Open head wounds
- Unstable airway or requirement for bag and mask ventilation, where cap application would affect clinical management
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CAPTURE:eegCap Application in Paediatrics wiTh redUced GCS in REsus
Children frequently present with altered or reduced consciousness levels to emergency departments. By using EEG monitoring, subclinical seizure activity may be detected, leading to earlier pharmacological intervention and improved outcomes. Post-ictal phases that may be interpreted as seizure activity may become less over-treated. A feasibility study will ascertain if EEG monitoring can be applied successfully in this cohort, within a specified time period, obtaining minimum artefact (defined as < 25% artefact). EEG recordings will not be used to guide clinical management during this feasibility study.
Read the detailed description
See study protocol attached
- Conditions
- Status Epilepticus, Altered Level of Consciousness, Non-epileptic Seizures, Epilepsy, Encephalopathy
- Keywords
- EEG, Emergency Department, Paediatrics, Reduced Glasgow Coma Scale (GCS)
- Medical subject headings
- Status Epilepticus, Consciousness Disorders, Seizures, Epilepsy, Brain Diseases, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of children who had EEG monitoring applied within twenty minutes and obtainment of an interpretable EEG recording with less than 25% artefact.
Measured: Anticipated 12 month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start5 Jul 2021
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status EpilepticusStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Deirdre Murray, University College Cork
- Investigators
- Deirdre Murray, Principal investigator, UCC and INFANT Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259891
- Sponsor's protocol ID
- DM01/UCC21
- Acronym
- CAPTURE
- Status last verified
- May 2023
- First submitted
- 18 Feb 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPTURE:eegCap Application in Paediatrics wiTh redUced GCS in REsus
- ClinicalTrials.gov ID
- NCT05259891
- Acronym / sponsor ID
- CAPTURE / DM01/UCC21
- Conditions
- Status Epilepticus, Altered Level of Consciousness, Non-epileptic Seizures, Epilepsy, Encephalopathy
- Keywords
- EEG, Emergency Department, Paediatrics, Reduced Glasgow Coma Scale (GCS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 2 Mar 2022 (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.
Children frequently present with altered or reduced consciousness levels to emergency departments. By using EEG monitoring, subclinical seizure activity may be detected, leading to earlier pharmacological intervention and improved outcomes. Post-ictal phases that may be interpreted as seizure activity may become less over-treated. A feasibility study will ascertain if EEG monitoring can be applied successfully in this cohort, within a specified time period, obtaining minimum artefact (defined as < 25% artefact). EEG recordings will not be used to guide clinical management during this feasibility study.
Detailed description
See study protocol attached
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 176 months
- Sex
- All
- Age groups
- Child
- Study population
- The study population is all children between 0 years and 15 years and 11 months who present to the Resuscitation room of the Emergency Department of Cork University Hospital. Children can have underlying co-morbidities ( eg neurodisability, epilepsy) or be their first time presenting to a hospital.
Key inclusion criteria (1 listed)
- Children between 0 and 15 years and 11 months who present to Resuscitation Room, ED, CUH with a Glasgow Coma Scale (GCS) < 11 or, a reduction in baseline GCS in the case of children with significant neurodisability at baseline
Key exclusion criteria (3 listed)
- Polytrauma
- Open head wounds
- Unstable airway or requirement for bag and mask ventilation, where cap application would affect clinical management
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
The percentage of children who had EEG monitoring applied within twenty minutes and obtainment of an interpretable EEG recording with less than 25% artefact.
Time frame: Anticipated 12 month study period
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 16 May 2023.
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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.
Deirdre Murray principal investigator
UCC and INFANT Centre
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 Status Epilepticus and Altered Level of Consciousness, run by University College Cork at 1 site in Ireland.
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 3 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 16 May 2023. 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 Ireland. 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?
The percentage of children who had EEG monitoring applied within twenty minutes and obtainment of an interpretable EEG recording with less than 25% artefact. (time frame: Anticipated 12 month study period). 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 16 May 2023.