Abstract
SummaryBackgroundDespite the availability of continuous conventional electroencephalography (cEEG), accurate diagnosis of neonatal seizures is challenging in clinical practice. Algorithms for decision support in the recognition of neonatal seizures could improve detection. We aimed to assess the diagnostic accuracy of an automated seizure detection algorithm called Algorithm for Neonatal Seizure Recognition (ANSeR).MethodsThis multicentre, randomised, two-arm, parallel, controlled trial was done in eight neonatal centres across Ireland, the Netherlands, Sweden, and the UK. Neonates with a corrected gestational age between 36 and 44 weeks with, or at significant risk of, seizures requiring EEG monitoring, received cEEG plus ANSeR linked to the EEG monitor displaying a seizure probability trend in real time (algorithm group) or cEEG monitoring alone (non-algorithm group). The primary outcome was diagnostic accuracy (sensitivity, specificity, and false detection rate) of health-care professionals to identify neonates with electrographic seizures and seizure hours with and without the support of the ANSeR algorithm. Neonates with data on the outcome of interest were included in the analysis. This study is registered with ClinicalTrials.gov, NCT02431780.FindingsBetween Feb 13, 2015, and Feb 7, 2017, 132 neonates were randomly assigned to the algorithm group and 132 to the non-algorithm group. Six neonates were excluded (four from the algorithm group and two from the non-algorithm group). Electrographic seizures were present in 32 (25·0%) of 128 neonates in the algorithm group and 38 (29·2%) of 130 neonates in the non-algorithm group. For recognition of neonates with electrographic seizures, sensitivity was 81·3% (95% CI 66·7–93·3) in the algorithm group and 89·5% (78·4–97·5) in the non-algorithm group; specificity was 84·4% (95% CI 76·9–91·0) in the algorithm group and 89·1% (82·5–94·7) in the non-algorithm group; and the false detection rate was 36·6% (95% CI 22·7–52·1) in the algorithm group and 22·7% (11·6–35·9) in the non-algorithm group. We identified 659 h in which seizures occurred (seizure hours): 268 h in the algorithm versus 391 h in the non-algorithm group. The percentage of seizure hours correctly identified was higher in the algorithm group than in the non-algorithm group (177 [66·0%; 95% CI 53·8–77·3] of 268 h vs 177 [45·3%; 34·5–58·3] of 391 h; difference 20·8% [3·6–37·1]). No significant differences were seen in the percentage of neonates with seizures given at least one inappropriate antiseizure medication (37·5% [95% CI 25·0 to 56·3] vs 31·6% [21·1 to 47·4]; difference 5·9% [–14·0 to 26·3]).InterpretationANSeR, a machine-learning algorithm, is safe and able to accurately detect neonatal seizures. Although the algorithm did not enhance identification of individual neonates with seizures beyond conventional EEG, recognition of seizure hours was improved with use of ANSeR. The benefit might be greater in less experienced centres, but further study is required.FundingWellcome Trust, Science Foundation Ireland, and Nihon Kohden.
Highlights
Newborn infants can exhibit a range of unusual repetitive movements, not all of which are seizures.[1]
Continuous conventional EEG monitoring is the gold standard for the diagnosis of all seizures.[11]
We identified six different research groups that assessed the performance of different seizure detection algorithms (SDAs) using at least 100 h of electroencephalography (EEG) monitoring from at least ten neonates
Summary
Newborn infants can exhibit a range of unusual repetitive movements, not all of which are seizures.[1] Recognition of seizures is vital because they are often a sign of an underlying neurological condition such as hypoxic ischaemic encephalopathy, stroke, or meningitis,[2,3] and because treatment for non-seizure events exposes infants to unnecessary harmful drugs.[4] The diagnosis of neonatal seizures is challenging for clinicians because most neonatal seizures are electrographic only, clinical signs can become uncoupled after medication, and, even when present, clinical signs can be subtle and hard to distinguish from the normal repertoire of neonatal movements.[5,6,7,8,9] Amplitude-integrated electroencephalography (aEEG) is often used by neonatologists for seizure detection, but limitations have been reported.[10] Continuous conventional EEG (cEEG) monitoring is the gold standard for the diagnosis of all seizures.[11] Evidence suggests that regardless of the underlying cause, seizures themselves have a negative effect on neurodevelopment, adding to the importance of early recognition and treatment.[12,13,14,15,16] Despite the availability of cEEG in some neonatal intensive care www.thelancet.com/child-adolescent Vol 4 October 2020
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