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

NCT02925988 | Terminated

• 1 other identifier: 0319-16-TLV-DM
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill

Keywords

Critically ill; High risk neonates

Outcome Measures

Primary Outcomes (1)

• Number of seizures detected

  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

  Through study completion, an average of 3 days

Secondary Outcomes (1)

• Number of events providing treatment-relevant information

  Through study completion, an average of 3 days

Study Arms (1)

EEG monitoring

OTHER

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

Interventions

EEG monitoring DEVICE

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.

EEG monitoring

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Neonates not eligible for EEG monitoring (e.g. patients with extensive cephalhematoma or subgaleal hemorrhage, interfering with the application of electrodes)

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Department of Neonatology Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dror Mandel, MD

  Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 6, 2016
• Study Start: January 5, 2017
• Primary Completion: April 22, 2018
• Study Completion: April 22, 2018
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)