Pilot Studies for Baltimore CPP/Pathways Followup

描述（由申请人提供）：由于对不利的围产期和早期婴儿风险因素与成年期出现的重要疾病之间的关系感兴趣，并有证据表明这一关系，联邦政府计划开展一项名为“全国儿童研究”的队列研究，研究对象超过10万名新生儿。NCS与20世纪60年代进行的一项名为“合作围产期项目”（CPP）的研究有相似之处，在该研究中，美国12所大学医学中心的58000名活产婴儿被跟踪到7岁或8岁。CPP包括有关怀孕和分娩的详细数据（包括孕产妇和脐带血清，仍可用于研究）；反复观察后代的身体、神经、认知和行为发育；出生和7岁时的社会和环境特征；以及胎儿、新生儿、后来的婴儿和儿童死亡。建议开展试点和发展工作，以支持CPP巴尔的摩队列的健康随访（n = 4034）。1992年至1994年间，在“成人之路研究”（PAS）中，对巴尔的摩CPP队列中2694名新生儿及其母亲进行了随机抽样调查。这项初步研究完成后的随访将在受试者年龄约为45岁时进行。首先需要进行试点工作，然后才能证明对巴尔的摩CPP进行更密集和全面后续行动的建议是合理的。首先，我们建议通过对160个后代的试点研究来评估队列成员可以定位并愿意参与后续研究的程度，根据他们在巴尔的摩CPP和PAS项目中的参与程度来定义四组。其次，我们建议评估将巴尔的摩CPP硬拷贝记录中的某些数据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，并与已有的1700多名受访者的数据进行比较，这些数据与年轻人的两种特定结果有关：心理健康和肥胖。在这项试点和发展工作取得成功之后，将提出对巴尔的摩CPP或整个巴尔的摩CPP队列中大量精心指定的样本进行健康随访的建议。健康随访将包括家访和体检。在计划的随访中，我们将采集血液中的DNA和其他生物标志物。后续行动将在这一队列中开始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）以及在中年发病的疾病（如糖尿病、高血压、心脏病和中风）联系起来的一系列原因。未来的项目还将建立在未来十年中这些疾病新发病风险的子样本。巴尔的摩CPP队列比任何其他CPP队列都得到了更深入的研究。拟议研究的数据将使NCS的数据提前近半个世纪。研究结果将产生关于对大范围流行、致残和致命健康状况的早期影响的新信息。

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.