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

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

Interventions

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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center

  lead OTHER_GOV

Principal Investigators

• Dror Mandel, MD · Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Day

Max Age

6 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-05

Primary Completion

2018-04-22

Completion

2018-04-22

Countries

• Israel

Study Locations