Pilot Studies for Baltimore CPP/Pathways Followup

描述（由申请人提供）：对围产期和早期婴儿不良风险因素与成年期出现的重要疾病之间关系的兴趣和证据，导致联邦政府计划进行一项名为国家儿童研究（NCS）的队列研究，研究对象为10万多名新生儿。NCS与20世纪60年代进行的一项名为围产期合作项目（CPP）的研究有相似之处，在该项目中，美国12所大学医学中心的58，000名活产婴儿被随访至7岁或8岁。CPP包括与妊娠和出生有关的详细数据（包括母体和脐带血清，仍可用于研究）;对后代的身体，神经，认知和行为发育的重复观察;出生和7岁时的社会和环境特征;以及胎儿，新生儿，后期婴儿和儿童死亡。 建议开展试点和开发工作，以支持CPP的巴尔的摩队列（n = 4034）的健康随访。在1992年至1994年期间，在成人之路研究（PAS）中，对巴尔的摩CPP出生队列中的2694名婴儿及其母亲进行了随机抽样调查。在完成这项拟议的试点研究时，将在该队列约45岁时进行拟议的随访。 在提出对巴尔的摩国别方案进行更深入和全面的后续行动的建议之前，需要进行试点工作。 首先，我们建议通过对160名后代进行试点研究，评估队列成员在多大程度上可以定位并愿意参与随访，分为四组，由他们在巴尔的摩CPP和PAS项目中的参与程度定义。其次，我们建议评估将某些数据从巴尔的摩CPP硬拷贝记录转换为磁性形式的成本和效用。第三，我们建议比较传统和新的统计技术，以了解特定胎儿生长轨迹的后果，已有1700多名受访者的数据，这些数据与年轻人的两个特定结果有关：心理健康和肥胖。 在这项试点和开发工作取得成功后，将提出对巴尔的摩CPP或可能是整个巴尔的摩CPP队列的大量精心指定样本进行健康随访的建议。健康跟踪将包括家庭访谈和医疗检查。在计划的随访中，我们将采集血液进行DNA和其他生物标志物检测。后续行动将开始在这一队列中研究将早期环境风险、胎儿和婴儿发育与青年期疾病（如精神状况）联系起来的原因链，直至中年发病的疾病（如糖尿病、高血压、心脏病和中风）。未来的项目还将确定在未来十年中有可能新发这些疾病的子样本。对巴尔的摩CPP队列的研究比任何其他CPP队列都要深入。拟议研究的数据将比NCS的数据提前近半个世纪。研究结果将产生关于早期影响的新信息，这些影响涉及广泛的流行、致残和致命的健康状况。

DESCRIPTION (provided by applicant): Interest in, and evidence or, the relationships between adverse perinatal and early infant risk factors, and important diseases emerging during adulthood, has led to plans by the Federal Government to conduct a cohort study called the National Children's Study (NCS) of over 100,000 births. The NCS has similarities to a study conducted during the 1960's called the Collaborative Perinatal Project (CPP), in which 58,000 live births were followed to age 7 or 8 in 12 university medical centers in the United States. The CPP included detailed data pertaining to pregnancy and birth (including maternal and cord sera, still available for study); repeated observations of the offspring's physical, neurological, cognitive, and behavioral development; social and environmental characteristics at birth and age 7; and fetal, neonatal, later infant, and child death. Pilot and developmental work is proposed in support of a health follow-up of the Baltimore cohort of the CPP (n = 4034). Between 1992 and 1994, a random sample of 2694 of the Baltimore CPP cohort of births, and their mothers, was surveyed, in the Pathways to Adulthood Study (PAS). The follow-up to be proposed at the completion of this proposed pilot study would occur when the cohort was about 45 years old. Pilot work is needed before a proposal for a more intensive and complete follow-up of the Baltimore CPP can be justified. First, we propose to assess the degree to which cohort members can be located and are willing to participate in a follow-up, by a pilot study of 160 offspring, in four groups defined by their level of participation in the Baltimore CPP and PAS projects. Second, we propose to evaluate the cost and utility of converting certain data from the Baltimore CPP hardcopy records to magnetic form. Third, we propose to compare traditional and new statistical techniques for understanding the consequences of specific fetal growth trajectories, with data on more than 1700 respondents, already in hand, relevant to two particular outcomes in young adults: mental health and obesity. Success in this pilot and developmental work will be followed by a proposal for health follow-up of a large and carefully designated sample of the Baltimore CPP, or possibly the entire Baltimore CPP cohort. The health follow-up will entail a household interview and medical examination. In the planned follow-up, we will obtain blood for DNA and other biomarkers. The follow-up will begin study in this cohort of the chain of causes linking early environmental risk, fetal, and infant development to disorders of young adulthood, such as mental conditions, through to diseases which have onset in middle age, such as diabetes, hypertension, heart disease, and stroke. The future project will also establish sub-samples at risk for new onset of these diseases in the coming decade of life. The Baltimore CPP cohort has been more intensively studied than any other CPP cohort. Data from the proposed study will anticipate those of the NCS by nearly half a century. The results will generate new information about early influences on a large range of prevalent, disabling and fatal health conditions.