跳至主要内容
临床试验/NCT03106493
NCT03106493已完成不适用

Upstate New York Infant Development Screening Program

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)0 个研究点目标入组 6,171 人开始时间: 2008年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6,171
主要终点
Blood Pressure

研究概览

简要总结

The goal of the Upstate KIDS Study is to track the growth, development and long-term health of children given the increasing use of infertility treatment, occurrence of maternal obesity and pregnancy complications, and rising maternal age at birth.

详细描述

The Upstate KIDS Study aims to determine if there are differences in health measures between children conceived by infertility treatment and children conceived naturally. In the first phase of the study, the focus was on growth and development through age 3 years. In the second phase of the study, the focus is turning to cardiometabolic factors through age 9 years. Infertility treatments include assisted reproductive technologies (ART) such as in vitro fertilization (IVF), controlled ovarian hyperstimulation (COH) and ovulation induction (OI). The study was originally designed as a matched exposure cohort. Specifically, singletons whose birth certificates indicated the use of infertility treatment were considered 'exposed' singleton infants and subsequently frequency-matched on perinatal region of birth at a ratio of 1:3 to 'unexposed' singletons. Twins and higher order multiples were invited to participate regardless of mode of conception. Mothers and their newborns were recruited approximately 2-4 months postpartum. The first phase of the study was completed in 2014 and main findings can be found under publications.

The second phase objectives are:

To determine whether infertility treatment is associated with differences in growth and development from age 6 to 8 years with particular focus on childhood cardio-metabolic outcomes by follow-up of children conceived by ART or other infertility treatments and children who were conceived without treatment. Secondarily, to assess epigenetic differences as measured by DNA methylation using collected biospecimens.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Mothers delivering a live birth in New York State (excluding New York City).

排除标准

  • Refused follow-up

结局指标

主要结局

Blood Pressure

时间窗: Through age 9 years

Measurement of blood pressure

次要结局

  • Motor milestone development(4-24 months)

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih
责任方
Sponsor

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