1. Effect of Treatment of Clinical Seizures vs Electrographic Seizures in Full-Term and Near-Term Neonates A Randomized Clinical Trial
- Author
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Hunt, RW, Liley, HG, Wagh, D, Schembri, R, Lee, KJ, Shearman, AD, Francis-Pester, S, DeWaal, K, Cheong, JYL, Olischar, M, Badawi, N, Wong, FY, Osborn, DA, Rajadurai, VS, Dargaville, PA, Headley, B, Wright, I, Colditz, PB, Hunt, RW, Liley, HG, Wagh, D, Schembri, R, Lee, KJ, Shearman, AD, Francis-Pester, S, DeWaal, K, Cheong, JYL, Olischar, M, Badawi, N, Wong, FY, Osborn, DA, Rajadurai, VS, Dargaville, PA, Headley, B, Wright, I, and Colditz, PB
- Abstract
IMPORTANCE: Seizures in the neonatal period are associated with increased mortality and morbidity. Bedside amplitude-integrated electroencephalography (aEEG) has facilitated the detection of electrographic seizures; however, whether these seizures should be treated remains uncertain. OBJECTIVE: To determine if the active management of electrographic and clinical seizures in encephalopathic term or near-term neonates improves survival free of severe disability at 2 years of age compared with only treating clinically detected seizures. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted in tertiary newborn intensive care units recruited from 2012 to 2016 and followed up until 2 years of age. Participants included neonates with encephalopathy at 35 weeks' gestation or more and younger than 48 hours old. Data analysis was completed in April 2021. INTERVENTIONS: Randomization was to an electrographic seizure group (ESG) in which seizures detected on aEEG were treated in addition to clinical seizures or a clinical seizure group (CSG) in which only seizures detected clinically were treated. MAIN OUTCOMES AND MEASURES: Primary outcome was death or severe disability at 2 years, defined as scores in any developmental domain more than 2 SD below the Australian mean assessed with Bayley Scales of Neonate and Toddler Development, 3rd ed (BSID-III), or the presence of cerebral palsy, blindness, or deafness. Secondary outcomes included magnetic resonance imaging brain injury score at 5 to 14 days, time to full suck feeds, and individual domain scores on BSID-III at 2 years. RESULTS: Of 212 randomized neonates, the mean (SD) gestational age was 39.2 (1.7) weeks and 122 (58%) were male; 152 (72%) had moderate to severe hypoxic-ischemic encephalopathy (HIE) and 147 (84%) had electrographic seizures. A total of 86 neonates were included in the ESG group and 86 were included in the CSG group. Ten of 86 (9%) neonates in the ESG and 4 of 86 (4%) in the CSG die
- Published
- 2021