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Infertility Treatment, Child Growth and Development Through Age Three Years

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:
7734824
负责人:
MARY L HEDIGER
金额:
$43.56万
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至

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中文摘要
翻译
这项研究的抽样范围是纽约州(NYS),不包括纽约市。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暴露婴儿队列的发育情况,即根据纽约围产期数据系统的记录,通过不孕症治疗怀孕的婴儿,以及没有接受这种治疗的婴儿。对于初级队列,总共1,500名经不孕症治疗(暴露)受孕的婴儿将在3-5个月大时被登记为参与者(如有必要,经妊娠纠正),并进行纵向跟踪,直到36个月(3岁),以及4,500名未暴露婴儿的队列,这些婴儿与居住在NYS区域围产期网络内并多次生育的婴儿频率匹配。研究参与者的所有同卵双胞胎将同时登记,并记录他们的结果(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跟踪(第二队列),尽管同卵双胞胎将不被视为主要队列的一部分。所有更高级别的倍数(三胞胎、四胞胎)也将按照相同的时间表登记和遵循,无论曝光状态如何。假设不孕症治疗的出生结局中约有25%是双胞胎或更高阶的倍数,二次队列的人数预计约为1,750人(暴露婴儿的450个双胞胎兄弟姐妹和未暴露婴儿的1,300个双胞胎兄弟姐妹)加上所有更高阶的倍数。所有婴儿都有资格被选中,不分种族、民族或性别。参照物(主要)出生队列的征募期预计将持续一年。 在纽约出生的婴儿的父母将被要求参加这项为期三年的研究:(A)填写关于怀孕的初步问卷,包括确认不孕症治疗、怀孕时间、婴儿喂养以及其他人口和社会经济因素(即产妇教育、职业)以及与运动和社会发展有关的混杂因素;(B)完成标准化筛查工具,了解儿童在4、8、12、16、20、24、30和36个月时的运动和社会发育情况;(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)。有关成长和病史的信息将以期刊形式从医生检查数据中收集。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)。
英文摘要
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. For the primary cohort, a total of 1,500 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 of 4,500 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. Assuming that approximately 25% of the birth outcomes from infertility treatment are twins or higher order multiples, the secondary cohort is expected to number about 1,750 (450 twin siblings of exposed and 1,300 twin siblings of unexposed infants) plus all higher order multiples. All infants are eligible for selection without regard to race, ethnicity or gender. The period of recruitment for the referent (primary) birth cohort is expected to last one calendar year. 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).
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