PROSPECTIVE STUDY OF THE OUTCOME OF ASEPTIC MENINGITIS I

无菌性脑膜炎结局的前瞻性研究 I

• 批准号: 3404793
• 负责人: JOHN F. MODLIN
• 金额: $ 22.06万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1986
• 资助国家: 美国
• 起止时间: 1986-05-01 至 1991-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3404793
• 关键词: Enterovirus; developmental neurobiology; disease /disorder proneness /risk; enzyme linked immunosorbent assay; gender difference; human subject; infant human (0-1 year); longitudinal human study; medical complication; nervous system disorder chemotherapy; nervous system disorder epidemiology; neuropsychological tests; preschool child (1-5); psychometrics; racial /ethnic difference; serology /serodiagnosis; socioeconomics; viral meningitis; virus antigen; virus classification

The long term prognosis of aseptic meningitis is generally thought to be benign. This presumption has been challenged recently by several retrospective studies which have suggested that as many as 16% of children who have enteroviral meningitis as young infants suffer significant neurological sequelae. Conclusions from these studies are limited by retrospective study design, criticism regarding control selection, and by small numbers of subjects. Discharge diagnosis data from hospitals in Maryland show that the rate of clinically recognized aseptic meningitis in infants under 12 months of age is more than 10-fold higher than for any other age group. Thus, aseptic meningitis has the highest attack rate in the age group that is most likely to suffer adverse neurological sequelae as a result of an inflammary insult occurring during a critical period of CNS development. This study is designed to assess potential neurological sequelae by prospectively following approximately 136 children who are admitted to one of three hospitals in Baltimore with aseptic meningitis between 8/1/85 and 10/31/89. Aseptic meningitis cases are to be enrolled during hospitalization for acute illness. Immediately following enrollment, 2 children will be selected as controls from the population of children residing in Baltimore who were born at the hospital where the index case has been admitted. Control children are to be matched with the index case for age, sex, race, socioeconomic status and educational opportunity. Study patients and controls will be asked to return for evaluation 4-5 weeks after discharge of the study patient, and when they reach 18 months, 30 months and 42 months of age. At each return visit, both patients and controls will be given neurological examinations and the Bayley Scale for Infant Development (BSID) will be administered at the one month follow-up, and 30 months of age; the Kaufman Assessment Battery for Children (KABC) will be used at 30 months and 42 months of age. The results of these evaluations will be compared for the cohort of study patients and the control cohort at each examination. The sample size, adjusted for anticipated drop-out, will be sufficient to detect a difference of 0.5 standard deviation on either test with a power ranging from 88% to 98% for the entire study sample. There will also be sufficient power to analyze the effect of age of patient, sex, race, socioeconomic status, enterovirus etiology, and severity of original infection on the long-term outcome of aseptic meningitis. If this study fails to demonstrate a significant effect on neurodevelopmental function, then infants with aseptic meningitis can be given an unequivocally good prognosis. If effects are demonstrated, then these data may stimulate efforts to prevent aseptic meningitis in young infants.

无菌性脑膜炎的长期预后通常被认为是 良性。 这一假设最近受到了一些人的质疑 回顾性研究表明，多达 16% 的儿童 年幼时患有肠道病毒性脑膜炎的人会遭受严重的痛苦 神经系统后遗症。 这些研究的结论受到以下因素的限制 回顾性研究设计、对对照选择的批评以及 科目数量少。 各医院出院诊断数据 马里兰州显示，临床上认可的无菌性脑膜炎的发生率 12个月以下婴儿的发病率是任何婴儿的10倍以上 其他年龄段。 因此，无菌性脑膜炎的发病率最高 最有可能遭受不良神经系统后遗症的年龄组 由于在关键时期发生炎症损伤 中枢神经系统发育。 本研究旨在评估潜在的神经系统后遗症 前瞻性地跟踪大约 136 名被一所学校录取的儿童 巴尔的摩 3 家医院在 85 年 8 月 1 日至 89 年 10 月 31 日。 无菌性脑膜炎病例应在 因急性疾病住院。 注册后立即，2 将从儿童群体中选择儿童作为对照 居住在巴尔的摩，在指示病例所在医院出生 已被录取。 对照儿童将与索引案例相匹配 年龄、性别、种族、社会经济地位和教育机会。 研究患者和对照者将被要求返回进行评估 4-5 研究患者出院后几周，以及当他们满 18 个月时， 30个月和42个月大。 每次回访时，患者和 对照者将接受神经系统检查和贝利量表 婴儿发育（BSID）将在一个月的随访中进行， 30 个月大；考夫曼儿童评估体系 (KABC) 将在30个月和42个月大时使用。 这些结果 将比较研究患者队列和 每次检查时的对照组。 样本量，调整为 预期的退出，足以检测到 0.5 的差异 任一测试的标准差，功效范围为 88% 到 98% 整个研究样本。 也会有足够的力量去分析 患者年龄、性别、种族、社会经济地位、肠道病毒的影响 病因和原始感染的严重程度对长期结果的影响 无菌性脑膜炎。 如果这项研究未能证明对 神经发育功能，那么患有无菌性脑膜炎的婴儿可以 给出了明确的良好预后。 如果效果得到证实，那么 这些数据可能会刺激预防年轻人无菌性脑膜炎的努力 婴儿。