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.

该研究的抽样框架是纽约州（NYS），不用纽约市。这项研究始于2007年9月4日，旨在使用基于人群的抽样策略来招募和比较匹配的曝光群体的婴儿队列，即，在不孕治疗的帮助下，从怀孕中鉴定出的婴儿，如纽约州围产期数据系统中所指出的那样，这些人在没有这种治疗的情况下都在孕育。不育治疗暴露是取样的基础，因为其相对稀有性。对于初级队列，被确定为不育治疗（暴露）被确定为3-5个月大的参与者（如有必要，请进行妊娠校正），并纵向遵循36个月（3岁），并与同类的婴儿一起，与未接触的婴儿，在纽约市的纽约州区域perinationaltimation Perinate Perinatal网络中频率匹配。所有研究参与者的所有联合链条都同时招募，他们的结果指出（例如，死产，新生儿死亡率），或者他们与研究参与者相同的时间表（次要队列），尽管Co-Twins不会被视为主要队列的一部分。高阶倍数（三胞胎，四倍）也被录入并按照相同的时间表遵循，无论暴露状态如何。招聘窗口从2008年9月17日（第一次邮寄）延长至2010年12月17日（收到的最终同意书），约为2年出生时间。密切监测招​​聘目标，以使最终招募的主要队列样本暴露于1,297个（不育治疗）和3,692个未暴露的母亲和婴儿，双胞胎约占每个队列的22％。 招募了45套高阶倍数（43个三重序，2个四倍），因此总共有5,034个母亲/婴儿套件。 通过：（a。）填写有关怀孕的初步问卷，包括确认不孕治疗，怀孕的时间，婴儿喂养以及其他人口统计学和社会经济因素（即，孕妇教育，职业）以及与运动和社会发展相关的混杂因素，包括确认，以及与运动和社会发展相关的混杂因素； （b。）完成一种标准化的筛查工具，该工具以年代或妊娠校正的年龄为4、8、12、16、20、24、30、30和36个月的儿童运动和社会发展； （c。）提供有关孩子的成长和病史的信息（例如，疾病，诊断出出生缺陷，重大损害）。有关生长和病史的信息以期刊格式从医生检查数据组装而成。记录将与其他相关的健康记录（例如，早期干预计划，WIC，出生缺陷或癌症注册机构）相关。 添加了其他几个组件：（a。）通过与基于辅助生殖技术（SART）基于周期的数据库联系来详细的艺术历史； （b。）从强制性的新生儿筛查和实验室测试中，对生物标志物和环境暴露的实验室测试遗留了残留的血液标本。血样在沃兹沃思中心实验室（纽约州卫生部）以及（c。）管理标准化评估的计划中拥有和存档，该计划使用一系列经验验证和可靠的工具进行了诊断出发育障碍的评估，以使所有神经传播症状的婴儿和儿童大约36个月大约36个月。 我们发现，鉴于出生证明的捕获艺术治疗相对于产妇报告很高，纽约州实时出生证明注册处是专注于艺术和儿童健康工作的合适抽样框架。 正在为关键研究问题进行数据分析。基线研究设计和方法论文已发表，以帮助其他研究人员进行类似研究的设计和行为。