Effect of Treatment of Clinical Seizures vs Electrographic Seizures in Full-Term and Near-Term Neonates: A Randomized Clinical Trial.

Autor:	Hunt RW; Department of Paediatrics, Monash University, Melbourne, Australia.; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Australia.; Monash Newborn, Monash Children's Hospital, Melbourne, Australia.; Cerebral Palsy Alliance, University of Sydney, Sydney, Australia.; Ritchie Centre, Hudson Institute of Medical Research, Monash University, Melbourne, Australia., Liley HG; Mater Mother's Hospital, Brisbane, Australia.; University of Queensland, Brisbane, Australia., Wagh D; Perth Children's Hospital, Perth, Australia., Schembri R; Clinical Epidemiology Biostatistics Unit, Murdoch Children's Research Institute, Melbourne, Australia., Lee KJ; Clinical Epidemiology Biostatistics Unit, Murdoch Children's Research Institute, Melbourne, Australia.; Department of Paediatrics, University of Melbourne, Melbourne, Australia., Shearman AD; Mater Mother's Hospital, Brisbane, Australia., Francis-Pester S; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Australia., deWaal K; Department of Neonatal Medicine, John Hunter Children's Hospital, Newcastle, Australia.; University of Newcastle, Callaghan, Australia., Cheong JYL; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Australia.; Neonatal Services, The Royal Women's Hospital, Melbourne, Australia.; Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia., Olischar M; University Children's Hospital, Vienna, Austria., Badawi N; Cerebral Palsy Alliance, University of Sydney, Sydney, Australia.; Grace Newborn Intensive Care, The Children's Hospital, Westmead, Australia., Wong FY; Department of Paediatrics, Monash University, Melbourne, Australia.; Monash Newborn, Monash Children's Hospital, Melbourne, Australia.; Ritchie Centre, Hudson Institute of Medical Research, Monash University, Melbourne, Australia., Osborn DA; Newborn Medicine, Royal Prince Alfred Hospital, Sydney, Australia.; University of Sydney, Sydney, Australia., Rajadurai VS; Department of Neonatology, KK Women's and Children's Hospital, Singapore., Dargaville PA; Neonatal and Paediatric Intensive Care Unit, Royal Hobart Hospital, Hobart, Australia.; Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia., Headley B; Department of Neonatal Medicine, Women's and Children's Hospital, Adelaide, Australia., Wright I; James Cook University, Cairns, Australia., Colditz PB; University of Queensland, Brisbane, Australia.; Royal Brisbane and Women's Hospital, Brisbane, Australia.
Jazyk:	angličtina
Zdroj:	JAMA network open [JAMA Netw Open] 2021 Dec 01; Vol. 4 (12), pp. e2139604. Date of Electronic Publication: 2021 Dec 01.
DOI:	10.1001/jamanetworkopen.2021.39604
Abstrakt:	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.
Databáze:	MEDLINE
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