Infertility Treatment, Child Growth and Development Through Age Three Years

不孕症治疗、三岁儿童生长发育

• 批准号: 8941515
• 负责人: Edwina Yeung
• 金额: $ 32.19万
• 依托单位: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8941515
• 关键词: Address; Affect; Age; Age-Months; Age-Years; Archives; Assisted Reproductive Technology; Attention; Bioethics; Biological Markers; Birth; Birth Certificates; Blindness; Blood specimen; Cerebral Palsy; Characteristics; Child; Child Development; Child health care; Childhood; Cognition; Conceptions; Congenital Abnormality; Consent; Couples; Data; Data Analyses; Databases; Decision Making; Demographic Factors; Development; Developmental Disabilities; Diabetes Mellitus; Diagnosis; Early Intervention; Education; Enrollment; Environmental Exposure; Fetal Growth Retardation; First Births; Frequencies; Goals; Growth; Growth and Development function; Head circumference; Health; Health Insurance; Health Professional; Health Services Accessibility; Hearing; High-Risk Pregnancy; Human; Hypertension; Impairment; Incidence; Infant; Infertility; Information Systems; Insurance Coverage; Investigation; Journals; Laboratories; Language; Lead; Left; Length; Link; Live Birth; Longitudinal Studies; Mails; Medical History; Mental Retardation; Methods; Minor; Monitor; Mothers; Motor; Motor Skills; Multiple Pregnancy; Neonatal; Neonatal Mortality; Neonatal Screening; Neurodevelopmental Impairment; New York; New York City; Obesity; Occupations; Outcome; Ovulation; Paper; Parents; Participant; Pattern; Perception; Perinatal; Pharmaceutical Preparations; Physicians; Population; Pregnancy; Premature Birth; Procedures; Publishing; Quadruplet Multiple Birth; Questionnaires; Recording of previous events; Records; Recruitment Activity; Registries; Relative (related person); Reporting; Research; Research Design; Research Personnel; Residual state; Risk; Sampling; Schedule; School-Age Population; Social Development; Societies; Socioeconomic Factors; Subgroup; Technology; Testing; Time; Treatment Efficacy; Treatment outcome; Triplet Multiple Birth; Twin Multiple Birth; Twin Studies; United States; Vision; Weight; Woman; Work; advanced maternal age; base; cohort; deafness; design; feeding; health record; improved; infancy; infant outcome; instrument; intervention program; neoplasm registry; neurodevelopment; older women; population based; psychosocial; reproductive; residence; screening; skills; stillbirth; tool

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) were 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 were enrolled simultaneously and either their outcomes noted (e.g., stillbirth, neonatal mortality) or they are being followed (secondary cohort) on the same schedule as Study participants, although the co-twins will not be considered as part of the primary cohort. Higher order multiples (triplets, quadruplets) were also enrolled and followed on the same schedule, regardless of exposure status. The recruitment window extended from September 17, 2008 (first mailing) through December 17, 2010 (final consent received), representing an approximate 2-year period of births. Recruitment goals were closely monitored so that the final recruited primary cohort sample was 1,297 exposed (infertility treatment) and 3,692 unexposed (no infertility treatment) mothers and infants, with twins making up about 22% of each cohort. There are 45 sets of higher order multiples (43 triplet, 2 quadruplets) recruited, such that there is a total of 5,034 mother/infant(s) sets. Parents of infants born in NYS are 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 are 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: (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 owned and 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 around 36 months of age for all infants and children who fail any of the neurodevelopmental screens. We found the NYS live birth certificate registry to be a suitable sampling framework for work focusing on ART and children's health, given that birth certificate's capture of ART treatment was high relative to maternal report. Data analysis is underway for key research questions The baseline study design and methods paper has been published to aid other investigators in the design and conduct of similar research.

本研究的抽样框架是纽约州 (NYS)，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来招募和比较匹配暴露队列的婴儿的发育情况，即根据纽约州围产期数据系统中的记录，在不孕不育治疗的帮助下怀孕的婴儿和未接受此类治疗的婴儿。由于其相对稀有性，不孕不育治疗暴露是抽样的基础。对于主要队列，被确定为通过不孕治疗（暴露）怀孕的婴儿在 3-5 个月大时被登记为参与者（如有必要，进行妊娠校正），并纵向跟踪直至 36 个月（3 岁），以及未暴露婴儿队列，在纽约州区域围产期网络中居住和多次出生的频率匹配。研究参与者的所有双胞胎均同时入组，并记录其结果（例如死产、新生儿死亡率），或者按照与研究参与者相同的时间表进行随访（第二队列），但双胞胎不会被视为主要队列的一部分。高阶多胞胎（三胞胎、四胞胎）也被登记并按照相同的时间表进行随访，无论暴露状态如何。招募窗口从2008年9月17日（首次邮寄）延长至2010年12月17日（收到最终同意），相当于大约2年的出生期。招募目标受到密切监控，最终招募的主要队列样本为 1,297 名暴露（不孕不育治疗）和 3,692 名未暴露（不孕不育治疗）母亲和婴儿，其中双胞胎约占每个队列的 22%。 招募了 45 组高阶多胞胎（43 组三胞胎，2 组四胞胎），因此总共有 5,034 组母亲/婴儿组。 在纽约州出生的婴儿的父母被要求参加为期三年的研究，方法是：(a.) 完成一份关于怀孕的初步调查问卷，包括，例如，确认不孕治疗、怀孕时间、婴儿喂养以及其他人口和社会经济因素（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，以解决儿童在 4、8、12、16、20、24、30 和 36 个月时的运动和社会发育问题； (c.) 提供有关儿童成长和病史的信息（例如疾病、出生缺陷诊断、重大损伤）。有关生长和病史的信息是根据医生检查数据以期刊形式汇总的。记录将与其他相关健康记录相关联（例如早期干预计划、WIC、出生缺陷或癌症登记）。 添加了几个额外的组成部分：(a.) 通过与辅助生殖技术协会 (SART) 基于周期的数据库链接来详细了解 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测试留下的残留血液样本。血液样本归沃兹沃斯中心实验室（纽约州卫生部）所有并存档，并且 (c.) 计划对 36 个月左右的所有未通过任何神经发育筛查的婴儿和儿童进行标准化评估，使用一系列经经验验证且可靠的仪器来诊断发育障碍。 我们发现纽约州活产证明登记处是关注 ART 和儿童健康工作的合适抽样框架，因为出生证明对 ART 治疗的捕获率相对于孕产妇报告而言较高。 正在进行关键研究问题的数据分析基线研究设计和方法论文已发表，以帮助其他研究人员设计和进行类似的研究。