Morbidity/Mortality and Disability in Children Study

儿童发病率/死亡率和残疾研究

• 批准号: 7023699
• 负责人: HEENA Pushkar BRAHMBHATT
• 金额: $ 11.02万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-16 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7023699
• 关键词: AIDS therapy; Africa; African; HIV infections; behavioral /social science research tag; child mental disorders; child physical development; children; clinical research; gestational age; human birth weight; human morbidity; human mortality; human subject; human therapy evaluation; longitudinal human study; malaria; neuropsychological tests; nevirapine; rural area; statistics /biometry; tuberculosis

DESCRIPTION (provided by applicant): Over 3 million African children are HIV-infected, but there is limited information on the development, health and social conditions of HIV-positive (HIV+) and HIV-negative (HIV-) children born to HIV-infected mothers. This study will assess the effects of HIV infection on child health and survival, in a cohort of 72 HIV+ and 228 HIV- but affected children born to HIV-infected mothers followed over 3. Children born during the study and their mothers/caretakers will be seen at birth, 4-6 weeks, 6 and 12 months, and annually thereafter. The specific aims are: To assess the effects of HIV infection in the child and/or the mother on:1) birth outcomes (birth weight, gestational age), 2) child health (morbidity), 3) growth and development (anthropometry), 4) neurodevelopmental disability (cognitive, motor, and behavioral disorders), and 5) mortality. The effects of antiretroviral therapy on each of these outcomes will also be assessed. Statistical methods will include Kaplan-Meier survival methods with log-rank tests for time to event analyses; proportional hazards models to estimate adjusted relative hazards for child outcomes with time-independent/dependent covariates; and regression methods for repeated measurements using population-average (marginal) and growth (conditional) models. The models will integrate the individual's baseline information, time-dependent risk factors, and recurrent event history into covariates for predicting future events, and provide a form of trajectory analyses. The study is nested within a decade-long community cohort in rural Rakai District, Uganda, which provides extensive information on maternal HIV status, sociodemographic, behavioral and health characteristics; and detailed data on households. The Rakai Program has an extensive field, clinical, laboratory and data management infrastructure. The multidisciplinary research team has the requisite expertise in epidemiology, clinical research, assessment of morbidity and disabilities, and in statistical analyses. In 2004, the Rakai Program received PEPFAR support for ARV provision and in 2005 was awarded a RO1 to assess ARV effects on HIV epidemiology and behaviors (1 R01 HD050180-01). However, the RO1 does not provide resources for detailed pediatric evaluations, particularly of neurodevelopmental disabilities, which will be a primary and original focus of this training and research application. Embedding the proposed study within the Rakai cohort draws upon unique resources and allows substantial cost savings. This study will provide critical information to guide interventions for improved care of HIV infected and HIV affected children in rural Uganda.

描述（由申请人提供）：超过 300 万非洲儿童感染艾滋病毒，但关于艾滋病毒阳性 (HIV+) 和艾滋病毒阴性 (HIV-) 所生儿童的发育、健康和社会状况的信息有限。受感染的母亲。这项研究将评估 HIV 感染对儿童健康和生存的影响，对 72 名 HIV 阳性和 228 名 HIV 阴性但受 HIV 感染的母亲所生的受影响儿童进行随访，对超过 3 名儿童进行随访。在研究期间出生的儿童及其母亲/照顾者将被纳入研究范围。出生时、4-6周、6个月和12个月以及此后每年观察一次。具体目标是： 评估 HIV 感染对儿童和/或母亲的影响：1) 出生结果（出生体重、胎龄），2) 儿童健康（发病率），3) 生长和发育（人体测量） , 4) 神经发育障碍（认知、运动和行为障碍），以及 5) 死亡率。还将评估抗逆转录病毒治疗对这些结果的影响。统计方法将包括 Kaplan-Meier 生存方法以及用于事件时间分析的对数秩检验；比例风险模型，用于估计具有时间独立/依赖协变量的儿童结局的调整后相对风险；使用人口平均（边际）和增长（条件）模型进行重复测量的回归方法。该模型将把个人的基线信息、时间相关的风险因素和经常发生的事件历史整合到协变量中以预测未来事件，并提供一种轨迹分析形式。该研究是在乌干达拉凯区农村地区长达十年的社区队列中进行的，该队列提供了有关孕产妇艾滋病毒状况、社会人口统计、行为和健康特征的广泛信息；以及家庭的详细数据。 Rakai 项目拥有广泛的现场、临床、实验室和数据管理基础设施。多学科研究团队在流行病学、临床研究、发病率和残疾评估以及统计分析方面拥有必要的专业知识。 2004 年，Rakai 计划获得了 PEPFAR 对提供 ARV 的支持，并于 2005 年获得了 RO1，以评估 ARV 对 HIV 流行病学和行为的影响（1 R01 HD050180-01）。然而，RO1 不提供详细的儿科评估资源，特别是神经发育障碍的评估，这将是本次培训和研究应用的主要和最初的重点。将拟议的研究嵌入 Rakai 队列中可以利用独特的资源并节省大量成本。这项研究将为指导干预措施提供重要信息，以改善乌干达农村地区艾滋病毒感染者和受艾滋病毒影响的儿童的护理。