Effect of Treatment of Clinical Seizures vs Electrographic Seizures in Full-Term and Near-Term Neonates: A Randomized Clinical Trial.
Effect of Treatment of Clinical Seizures vs Electrographic Seizures in Full-Term and Near-Term Neonates: A Randomized Clinical Trial.
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临床癫痫发作的治疗与完整期和近期新生儿的电学癫痫发作的影响：一项随机临床试验。
DOI：
10.1001/jamanetworkopen.2021.39604
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发表时间：
2021-12-01
影响因子：
13.8
通讯作者：
Newborn Electrographic Seizure Trial Investigators
中科院分区：
文献类型：
--
作者：
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;Newborn Electrographic Seizure Trial Investigators
这项随机对照试验确定了与仅治疗临床检测到的癫痫发作相比，对脑病足月或近足月新生儿进行电描记和临床癫痫发作的积极治疗是否能提高2岁时无严重残疾的生存率。与单独治疗临床癫痫发作相比，治疗足月或近足月新生儿的所有电描记癫痫发作是否改善了2年时的结局？这项随机临床试验分析了212名癫痫发作高危新生儿，其中84%有电描记癫痫发作。几乎没有证据表明两组之间的死亡率或神经发育障碍存在差异。这些结果表明，在癫痫发作病因异质性的足月或近足月新生儿中，使用常规抗惊厥药治疗电描记癫痫发作与结局无关。新生儿期癫痫发作与死亡率和发病率增加有关。床旁振幅整合脑电图（aEEG）有助于检测电描记癫痫发作;然而，是否应治疗这些癫痫发作仍不确定。确定与仅治疗临床检测到的癫痫发作相比，对脑病性足月或近足月新生儿进行电描记和临床癫痫发作的积极治疗是否能改善2岁时无严重残疾的生存率。这项随机临床试验在2012年至2016年招募的三级新生儿重症监护室进行，并随访至2岁。参与者包括妊娠35周或以上且小于48小时的脑病新生儿。数据分析已于二零二一年四月完成。随机分配至电描记癫痫发作组（ESG）或临床癫痫发作组（CSG），在ESG中，除临床癫痫发作外，还治疗aEEG检测到的癫痫发作，在CSG中，仅治疗临床检测到的癫痫发作。主要结局为2年时的死亡或重度残疾，定义为任何发育领域的评分低于澳大利亚平均值2 SD以上（采用Bayley新生儿和幼儿发育量表第3艾德（BSID-III）评估），或存在脑瘫、失明或耳聋。次要结局包括5 - 14天时的磁共振成像脑损伤评分、至完全吸吮喂养的时间和2年时BSID-III的个体领域评分。在212例随机化新生儿中，平均（SD）胎龄为39.2（1.7）周，122例（58%）为男性; 152例（72%）有中度至重度缺氧缺血性脑病（HIE），147例（84%）有电描记癫痫发作。共有86名新生儿被纳入ESG组，86名被纳入CSG组。ESG组86名新生儿中有10名（9%）在2年评估前死亡，CSG组86名新生儿中有4名（4%）在2年评估前死亡。ESG组与CSG组相比，主要结局的比值没有显著差异（ESG组，86例中的38例[44%] vs CSG组，86例中的27例[31%];比值比[OR]，1.83; 95%CI，0.96 - 3.49; P = 0.14）。在HIE患者中也没有显著差异（OR，1.77; 95%CI，0.84 - 3.73; P = 0.26）。有证据表明，ESG的认知结果更差（平均[SD]评分，ESG：97.4 [17.7] vs CSG：103.8 [17.3];平均差异，-6.5 [95%CI，-1.2至-11.8]; P = 0.01）。几乎没有证据表明次要结局存在差异，包括吸吮饲料的时间，癫痫发作负担或脑损伤评分。在一组异质性癫痫发作新生儿中，用目前使用的抗惊厥药治疗电描记和临床癫痫发作并不能显著降低2年时的死亡率或残疾率。http://anzctr.org.au标识符：ACTRN 12611000327987
This randomized control trial determines 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. Does the treatment of all electrographic seizures in term or near-term neonates improve outcome at 2 years when compared with the treatment of clinical seizures alone? This randomized clinical trial analyzed 212 neonates at a high risk of seizures, 84% of whom had electrographic seizures. There was little evidence of a difference in either mortality or neurodevelopment impairment between the 2 groups. These findings suggest that in full-term or near-term neonates with heterogeneous etiologies for seizures, treatment of electrographic seizures with conventional anticonvulsants was not associated with outcome. 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. 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. 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. 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. 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. 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. 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. http://anzctr.org.au Identifier: ACTRN12611000327987
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DOI：
10.1016/j.yebeh.2011.07.022
发表时间：
2011-10
期刊：
Epilepsy & behavior : E&B
影响因子：
--
作者：
Kleen JK;Sesqué A;Wu EX;Miller FA;Hernan AE;Holmes GL;Scott RC
通讯作者：
Scott RC
影响因子：
5.1
作者：
Glass, Hannah C.;Glidden, David;Jeremy, Rita J.;Barkovich, A. James;Ferriero, Donna M.;Miller, Steven P.
通讯作者：
Miller, Steven P.
影响因子：
11.2
作者：
Cornejo, Brandon J.;Mesches, Michael H.;Benke, Timothy A.
通讯作者：
Benke, Timothy A.
DOI：
10.1001/archpediatrics.2010.20
发表时间：
2010-04-01
影响因子：
--
作者：
Anderson, Peter J.;De Luca, Cinzia R.;Doyle, Lex W.
通讯作者：
Doyle, Lex W.
DOI：
10.1136/adc.2009.165969
发表时间：
2010-05-01
影响因子：
4.4
作者：
Evans, E.;Koh, S.;Garg, M.
通讯作者：
Garg, M.