- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02925988
Combined Amplitude-integrated and Conventional EEG Monitoring in High-risk Critically Ill Neonates
Combined Amplitude-integrated and Conventional EEG Monitoring in High-risk Critically Ill Neonates: A Pilot Study
Study Overview
Detailed Description
HYPOTHESIS
An algorithm combining conventional and amplitude-integrated EEG monitoring will increase specificity and sensitivity of seizure detection in critically ill high-risk neonates in a resource-restricted environment.
OBJECTIVES
- To describe the sensitivity and specificity of amplitude-integrated EEG (aEEG) relative to conventional EEG (cEEG) monitoring in high-risk critically ill neonates
- To evaluate the feasibility of an algorithm combining amplitude-integrated and conventional EEG monitoring in high-risk critically ill neonates
Long-term Objectives
The proposed pilot research project will provide fundamental information essential for designing a future larger scale study analyzing a standardized algorithm of combined continuous EEG monitoring for high-risk critically ill neonates at the investigators NICU, with the ultimate goal of preventing secondary brain injury in these patients.
Parents of potentially eligible patients will be approached by a study team member and will receive study information.
Consent will be attained after sufficient time to review the consent form and to ask questions.
This is a prospective study. We are aiming to enroll 20 neonates at high risk for seizures, consecutively.
Monitoring
Electrode positioning:
The aEEG and the cEEG consist of 3 to 5 and of 8 to 14 electrodes respectively.
Neonatal EEG application and set up will follow the international standard protocol in use at the investigators NICU.
The electrodes will not be replaced unless there is a signal interruption. A local skin lesions might occur, in very rare cases, when prolonged EEG ( over 2-3 days).
Monitoring protocol:
Neonates will receive their amplitude-integrated EEG monitoring as soon as the indication for monitoring is established, and conventional EEG electrodes will be applied in parallel, as soon as an EEG technician is available, which should usually be within less than 16 hours, in many cases within 1-4 hours.
Amplitude-integrated EEGs will be read and interpreted continuously, as currently standard of care at the investigators NICU. Conventional EEGs will be interpreted by a neurologist. During the review process, the neurology conventional EEG interpretation team will be blinded to the results of the amplitude-integrated EEG read by the neonatology team, and vice versa.
Electrographic seizure events or other clinically relevant findings (e.g. abnormalities of background activity) will be communicated to the NICU staff (in accordance with current practice).
EEG monitoring will be performed for as long as current NICU guidelines require.
Measures captured will include:
- Time and duration of seizures as per clinical observation
- Time and duration of seizure as per amplitude integrated EEG
- Time and duration of seizure as per conventional EEG
- Time and duration of background activity abnormality as per amplitude integrated EEG
- Time and duration of background activity abnormality as per conventional EEG
- Other relevant findings on amplitude integrated EEG (e.g. localization-related)
- Other relevant findings on conventional EEG (e.g. localization-related)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tel Aviv, Israel, 64239
- Department of Neonatology Tel Aviv Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Neonates admitted to our NICU
- Neonates identified to require aEEG monitoring as per current NICU guidelines (all neonates receiving therapeutic hypothermia as well as neonates with clinical events suggestive of seizures)
Exclusion Criteria:
- Neonates not eligible for EEG monitoring (e.g. patients with extensive cephalhematoma or subgaleal hemorrhage, interfering with the application of electrodes)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: EEG monitoring
Neonates will receive their aEEG monitoring as soon as the indication for monitoring is established, and cEEG electrodes will be applied in parallel, as soon as an EEG technician is available, which should usually be within less than 16 hours, in many cases within 1-4 hours.
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Neonates will receive their amplitude-integrated EEG monitoring as soon as the indication for monitoring is established, and conventional EEG electrodes will be applied in parallel.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of seizures detected
Time Frame: Through study completion, an average of 3 days
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Through study completion, an average of 3 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of events providing treatment-relevant information
Time Frame: Through study completion, an average of 3 days
|
|
Through study completion, an average of 3 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dror Mandel, MD, Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0319-16-TLV-DM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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