eegCap Application in Paediatrics wiTh redUced GCS in REsus

NCT ID: NCT05259891

Last Updated: 2023-05-16

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

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-05

Study Completion Date

2022-06-20

Brief Summary

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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

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See study protocol attached

Conditions

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Status Epilepticus Altered Level of Consciousness Non-epileptic Seizures Epilepsy Encephalopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Polytrauma
* Open head wounds
* Unstable airway or requirement for bag and mask ventilation, where cap application would affect clinical management
Minimum Eligible Age

0 Months

Maximum Eligible Age

176 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College Cork

OTHER

Sponsor Role lead

Responsible Party

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Dr. Deirdre Murray

Associate Professor and Consultant Paediatrician, Department of Paediatrics and Child Health and INFANT, UCC, Cork University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deirdre Murray

Role: PRINCIPAL_INVESTIGATOR

UCC and INFANT Centre

Locations

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Cork University Hospital (CUH)

Cork, Munster, Ireland

Site Status

Countries

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Ireland

Other Identifiers

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DM01/UCC21

Identifier Type: -

Identifier Source: org_study_id

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