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: 3404792
• 负责人: JOHN F. MODLIN
• 金额: $ 21.28万
• 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/3404792
• 关键词: Enterovirus; 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 良性的 这一假设最近受到了一些人的挑战。 回顾性研究表明，多达16%的儿童 患有肠病毒性脑膜炎的婴儿 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，关于对照选择的批评，以及 少数科目。 年医院出院诊断数据 马里兰州的研究表明， 12个月以下婴儿的死亡率比任何 其他年龄组。 因此，无菌性脑膜炎的发病率最高， 最有可能遭受不良神经后遗症年龄组 由于在一个关键时期发生的炎症性损伤， CNS发展。 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名儿童， 巴尔的摩的三家医院在1985年8月1日至1999年8月1日期间 10/31/89. 无菌性脑膜炎病例将在 急性病住院治疗。 入组后，2 将从儿童人群中选择儿童作为对照 居住在巴尔的摩，出生在医院， 被录取了 对照儿童将与索引病例匹配 年龄、性别、种族、社会经济地位和教育机会。 将要求研究患者和对照患者返回进行评价4-5 在研究患者出院后18周，以及当他们达到18个月时， 30个月和42个月大。 在每次回访时，患者和 对照组将进行神经系统检查和Bayley量表， 将在1个月随访时进行婴儿发育（BSID）， 考夫曼儿童成套评估（KABC） 将在30个月和42个月大时使用。 的结果予以 将比较研究患者队列的评价， 每次检查时的对照队列。 样本量，调整为 预期脱落足以检测到0.5的差异 任一检验的标准差，把握度范围为88%至98%， 整个研究样本。 也会有足够的力量来分析 患者年龄、性别、种族、社会经济状况、肠道病毒 病原学和原始感染的严重程度对 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 因为预后很好 如果效果得到证实， 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。