- Title
- Effect of Treatment of Clinical Seizures vs Electrographic Seizures in Full-Term and Near-Term Neonates: A Randomized Clinical Trial
- Creator
- Hunt, Rod W.; Liley, Helen G.; Badawi, Nadia; Wong, Flora Y.; Osborn, David A.; Rajadurai, Victor Samuel; Dargaville, Peter A.; Headley, Bevan; Wright, Ian; Colditz, Paul B.; Wagh, Deepika; Schembri, Rachel; Lee, Katherine J.; Shearman, Andrew D.; Francis-Pester, Samantha; deWaal, Koert; Cheong, Jeanie Y. L.; Olischar, Monika
- Relation
- JAMA Network Open Vol. 4, Issue 12, no. e2139604
- Publisher Link
- http://dx.doi.org/10.1001/jamanetworkopen.2021.39604
- Publisher
- American Medical Association
- Resource Type
- journal article
- Date
- 2021
- Description
- 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 died before the 2-year assessment. The odds of the primary outcome were not significantly different in the ESG group compared with the CSG group (ESG, 38 of 86 [44%] vs CSG, 27 of 86 [31%]; odds ratio [OR], 1.83; 95% CI, 0.96 to 3.49; P = .14). There was also no significant difference in those with HIE (OR, 1.77; 95% CI, 0.84 to 3.73; P = .26). There was evidence that cognitive outcomes were worse in the ESG (mean [SD] scores, ESG: 97.4 [17.7] vs CSG: 103.8 [17.3]; mean difference, −6.5 [95% CI, −1.2 to −11.8]; P = .01). There was little evidence of a difference in secondary outcomes, including time to suck feeds, seizure burden, or brain injury score. Conclusions and Relevance: Treating electrographic and clinical seizures with currently used anticonvulsants did not significantly reduce the rate of death or disability at 2 years in a heterogeneous group of neonates with seizures. Trial Registration: http://anzctr.org.au Identifier: ACTRN12611000327987.
- Subject
- seizures; neonatal; amplitude-integrated electroencephalography (aEEG); hypoxic-ischemic encephalopathy (HIE)
- Identifier
- http://hdl.handle.net/1959.13/1491785
- Identifier
- uon:53197
- Identifier
- ISSN:2574-3805
- Rights
- x
- Language
- eng
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