Continuous video electroencephalography (cEEG) monitoring is the recommended gold standard of care for at-risk neonates but is not available in many Neonatal Intensive Care Units (NICUs). To conduct a randomized treatment trial of levetiracetam for the first-line treatment of neonatal seizures (the NEOLEV2 trial), we developed a monitoring infrastructure at five NICUs, implementing recent technological advancements to provide continuous video EEG monitoring and real-time response to seizure detection. Here, we report on the feasibility of providing this level of care.
Twenty-five key informant interviews were conducted with study neurologists, neonatologists, coordinators, and EEG technicians from the commercial EEG monitoring company Corticare. A general inductive approach was used to analyze these qualitative data.
A robust infrastructure for continuous video EEG monitoring, remote review, and real-time seizure detection was established at all sites. At the time of this survey, 260 babies had been recruited and monitored for 2 to 6 days. The EEG technician review by the commercial EEG monitoring company was reassuring to families and neonatologists and led to earlier detection of seizures but did not reduce work load for neurologists. Neurologists found the automated neonatal seizure detector algorithm provided by the EEG software company Persyst useful, but the accuracy of the algorithm was not such that it could be used without review by human expert. Placement of EEG electrodes to initiate monitoring, especially after hours, remains problematic.
Technological advancements have made it possible to provide at-risk neonates with continuous video EEG monitoring, real-time detection of and response to seizures. However, this standard of care remains unfeasible in usual clinical practice. Chief obstacles remain starting a recording and resourcing the real-time specialist review of suspect seizures.
*Paediatric Neurology, Auckland District Health Board, Auckland, New Zealand;
†Department of Neurosciences, Rady Children's Hospital San Diego, University of California, San Diego, California;
‡Department of Neurosciences, University of California, San Diego, California;
Departments of §Neonatology and
‖Pediatric Neurology, UCSF Benioff Children's Hospital, San Francisco, California;
¶Department of Pediatrics, Rady Children Hospital San Diego, University of California, San Diego, California;
#Division of Neonatology, Rady Children's Hospital, San Diego, California;
**School of Nursing, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand;
††Neonatology, Auckland District Health Board, Auckland, New Zealand;
‡‡Division of Neonatology, Department of Pediatrics, University of California, San Diego, California;
§§San Diego Neonatology Inc, Sharp Mary Birch Hospital for Women and Newborns, San Diego, California;
‖‖Neonatal Research Institute, Sharp Mary Birch Hospital for Women and Newborns, San Diego, California;
¶¶Department of Neurosciences, Sharp Mary Birch Hospital for Women and Newborns, University of California, San Diego; and
##Departments of Pediatrics and Neurosciences, Rady Children's Hospital San Diego, University of California, San Diego, California.
Address correspondence and reprint requests to Cynthia Sharpe, MBChB, Paediatric Neurology, Starship Children's Hospital, Park Road, Private Bag 92-024, Auckland 1142, New Zealand; e-mail: firstname.lastname@example.org.
The authors have no funding or conflicts of interest to disclose.
The Persyst EEG software company has worked closely with the authors on the NEOLEV2 study and has provided their software to the researchers free of charge but has had no input into this feasibility study or this manuscript. The Corticare commercial EEG monitoring company has worked closely with the authors on the NEOLEV2 study on a commercial basis. This company has had no input into the writing of this manuscript. This manuscript discusses use of the automated neonatal seizure detection algorithm created by the Persyst EEG software company, which is not yet FDA-approved for commercial use.
The NEOLEV2 study was funded by the FDA 1 RO1FD004147-01A1.
Presented as an abstract at the Pediatric Academic Society Meeting, San Francisco, May 10, 2017.
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