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300万非洲儿童感染了HIV，但有关HIV阳性（HIV+）和HIV阴性（HIV-）儿童的发展，健康和社会状况的信息有限。这项研究将评估艾滋病毒感染对儿童健康和生存的影响，在72 HIV+和228名HIV-中，但受HIV感染的母亲出生的受影响的儿童受到了3人的影响。在研究期间出生的孩子及其母亲/看护者将在出生时，4-6周，6和12个月出生时，每年每年出生。具体目的是：评估艾滋病毒感染对儿童和/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），3）生长和发育（人体测定法），4）神经疾病残疾（认知，摩托和行为障碍），以及5）抵押。还将评估抗逆转录病毒疗法对这些结果的每一个的影响。统计方法将包括Kaplan-Meier生存方法，并使用对数秩检验进行活动分析；比例危害模型，以估计与时间无关/依赖的协变量对儿童结局的相对危害；使用人口平均（边际）和增长（条件）模型的重复测量方法的回归方法。这些模型将将个人的基线信息，时间依赖性风险因素和经常性事件历史记录整合到预测未来事件的协变量中，并提供轨迹分析的一种形式。这项研究嵌套在乌干达农村地区十年的社区队列中，该地区提供了有关孕产妇艾滋病毒状况，社会人口统计学，行为和健康特征的广泛信息；以及有关家庭的详细数据。 Rakai计划具有广泛的领域，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具有必要的专业知识。 2004年，Rakai计划获得了对ARV提供的PEPFAR支持，并在2005年获得了RO1，以评估对HIV流行病学和行为的影响（1 R01 HD050180-01）。但是，RO1并未为详细的小儿评估提供资源，特别是神经发育障碍，这将是本培训和研究应用程序的主要和原始重点。将拟议的研究嵌入Rakai队列中可以利用独特的资源，并可以节省大量成本。这项研究将提供关键信息，以指导干预措施改善乌干达乡村的艾滋病毒感染和艾滋病毒影响儿童的护理。