Infertility Treatment, Child Growth and Development Through Age Three Years

研究的抽样范围是纽约州，不包括纽约市。该研究于2007年9月4日开始，旨在使用基于人群的抽样策略招募和比较一个匹配暴露队列婴儿的发展，即，根据纽约州围产期数据系统的记录，在不孕症治疗的帮助下怀孕的婴儿，以及在没有这种治疗的情况下怀孕的婴儿。不孕症治疗暴露是抽样的基础，因为它相对罕见。对于主要队列，确定为通过不孕治疗（暴露）受孕的婴儿在3-5月龄（如有必要，进行妊娠校正）时入组为受试者，并与未暴露婴儿队列一起进行纵向随访，直至36月龄（3岁），与NYS区域围产期网络内的居住频率匹配和多次出生的婴儿队列一起进行沿着。研究受试者的所有双胞胎应同时入组，并记录其结局（例如，死产、新生儿死亡），或者按照与研究参与者相同的时间表对其进行随访（第二队列），尽管双胞胎不被视为主要队列的一部分。无论暴露状态如何，所有更高阶倍数（三胞胎、四胞胎）也将入组并按照相同的时间表进行随访。参考（主要）出生队列的招募期于2008年9月开始，目前仍在进行中。 在纽约州出生的婴儿的父母将被要求参加为期三年的研究：（a）完成关于怀孕的初始问卷，包括例如不孕症治疗的确认、怀孕时间、婴儿喂养和其他人口统计学和社会经济因素（即，母亲教育、职业）以及与运动和社会发展相关的混杂因素;（B.）完成标准化筛查工具，其解决他们的查尔兹孩子在按时间顺序或经妊娠校正的年龄4、8、12、16、20、24、30和36个月时的运动和社会发育;以及（c.）提供有关儿童生长和病史的信息（例如，疾病、出生缺陷诊断、重大损伤）。关于生长和病史的信息将以期刊的形式从医生的检查数据中收集。记录将链接到其他相关的健康记录（例如，早期干预计划、WIC、出生缺陷或癌症登记）。 今年增加了几个新的组成部分：（a）通过与辅助生殖技术协会（SART）基于周期的数据库链接，提供详细的ART历史;（B.）采集强制性新生儿筛查和生物标志物和环境暴露实验室检测后留下的残留血液样本。血液样本在沃兹沃斯中心实验室（纽约州卫生部）存档，和（c.）计划对所有未通过任何神经发育筛查的婴儿和儿童在24-30个月时使用一组经经验验证的可靠工具进行标准化评估，以诊断发育障碍。

The sampling frame for the Study is New York State (NYS), exclusive of New York City. The Study, which began September 4, 2007, is designed to use a population-based sampling strategy to recruit and compare the development of a matched-exposure cohort of infants, i.e., infants identified from pregnancies conceived with the help of infertility treatment, as noted in the NYS Perinatal Data System, and infants who were conceived without such therapies. The infertility treatment exposure is the basis for the sampling because of its relative rarity. For the primary cohort, infants identified as having been conceived by infertility treatment (exposed) are to be enrolled as participants at 3-5 months of age (gestation-corrected, if necessary) and followed longitudinally until age 36 months (3 years), along with a cohort unexposed infants, frequency-matched for residence within a NYS Regional Perinatal Network and plurality of birth. All co-twins of Study participants are to be enrolled simultaneously and either their outcomes noted (e.g., stillbirth, neonatal mortality), or they are to be followed (secondary cohort) on the same schedule as Study participants, although the co-twins will not be considered as part of the primary cohort. All higher order multiples (triplets, quadruplets) are also to be enrolled and followed on the same schedule, regardless of exposure status. The period of recruitment for the referent (primary) birth cohort began in September, 2008, and is on-going. Parents of infants born in NYS will be asked to participate in the Study for three years by: (a.) completing an initial questionnaire about the pregnancy, including, for example, confirmation of infertility treatment, time-to-pregnancy, infant feeding, and other demographic and socioeconomic factors (i.e., maternal education, occupation) and confounders associated with motor and social development; (b.) completing a standardized screening instrument that addresses their childs motor and social development at chronologic or gestation-corrected ages 4, 8, 12, 16, 20, 24, 30, and 36 months; and (c.) providing information on the child's growth and medical history (e.g., illnesses, diagnoses of birth defects, major impairments). Information on growth and medical history will be assembled in journal format from physicians examination data. Records will be linked to other pertinent health records (e.g., early intervention programs, WIC, birth defect or cancer registries). Several additional components have been added in this year: (a.) a detailed ART history by linking with the Society for Assisted Reproductive Technology (SART) cycle-based database; (b.) the acquisition of residual blood specimens left over from mandatory neonatal screening and laboratory testing for biomarkers and environmental exposures. The blood specimens are archived at the Wadsworth Center Laboratories (New York State Department of Health), and (c.) plans for the administration of a standardized assessment for diagnosing developmental disabilities using a battery of empirically validated and reliable instruments at 24-30 months of age for all infants and children who fail any of the neurodevelopmental screens.