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Combined Amplitude-integrated and Conventional EEG Monitoring in High-risk Critically Ill Neonates

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ClinicalTrials.gov Identifier: NCT02925988
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:
Over the past decade, technical advances have improved the efficiency of continuous EEG recording and remote review, leading to a steep increase in the number of continuous EEGs performed, and to an emerging change in what is considered the standard of care with regards to brain monitoring. Critically ill patients are at high risk for CNS insults, which can result in permanent neurologic disability if untreated. Non-convulsive status epilepticus and other secondary brain injuries are often unrecognized without continuous EEG monitoring. There is increasing evidence that continuous EEG monitoring facilitates early identification and management of changes in brain function, and a recent consensus statement concludes that "each center should provide critical care continuous EEG at the highest level that local resources allow". Neonatal neuro-intensive care is a rapidly developing field with a focus on monitoring of the developing brain. Without continuous EEG monitoring, neonates with paroxysmal events that are suspicious for seizures are treated with phenobarbital, often for many months, with inherent risks of side effects. Because paroxysmal events in neonates may or may not represent seizures, and electrographic seizures may have no discernable clinical correlate, this approach fails to adequately diagnose seizures and exposes neonates to possible harm, either by medication overuse for paroxysmal events that have no electrographic correlate, or by under-treatment of seizures without clinical manifestations. Amplitude-integrated EEG technology is now increasingly used as a simplified monitoring method, using fewer numbers of electrodes and usually being interpreted by a neonatologist or trainee. This model has been implemented at the investigators NICU. However, a recent systematic review came to the conclusion that amplitude-integrated EEG has relatively low and variable sensitivity and specificity, and therefore should not be the mainstay for diagnosis and management of neonatal seizures. Continuous video EEG monitoring is recommended as the gold standard for critically ill neonates, but is a very expensive and resource-intense method. An approach combining both techniques in a standardized algorithm may provide improved patient care in a resource-restricted environment. The investigators are planning to test this hypothesis in a pilot project.

Condition or disease Intervention/treatment Phase
Critically Ill Device: EEG monitoring Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Combined Amplitude-integrated and Conventional EEG Monitoring in High-risk Critically Ill Neonates: A Pilot Study
Actual Study Start Date : January 5, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
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.
Device: EEG monitoring
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.




Primary Outcome Measures :
  1. Number of seizures detected [ Time Frame: Through study completion, an average of 3 days ]
    1. Number of seizures detected via conventional, but not amplitude-integrated EEG
    2. Number of seizures detected via amplitude-integrated EEG that in fact were not seizures on interpretation via conventional EEG


Secondary Outcome Measures :
  1. Number of events providing treatment-relevant information [ Time Frame: Through study completion, an average of 3 days ]
    1. Number of events where cEEG monitoring provide treatment-relevant information that would not have been available with aEEG monitoring alone
    2. Number of events where cEEG monitoring provide clinically relevant information that would not have been available with aEEG monitoring alone (e.g. abnormality of background activity, localization findings)



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925988


Contacts
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Contact: Dror Mandel, MD +97236925690 drorm@tlvmc.gov.il

Locations
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Israel
Department of Neonatology Tel Aviv Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Dror Mandel, MD    +97236925690    drorm@tlvmc.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Dror Mandel, MD Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center

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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02925988     History of Changes
Other Study ID Numbers: 0319-16-TLV-DM
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tel-Aviv Sourasky Medical Center:
Critically ill
High risk neonates
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes