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临床试验/NCT01741051
NCT01741051
已完成
不适用

A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community

Simon Fraser University1 个研究点 分布在 1 个国家目标入组 540 人2014年1月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Fetal Growth Restriction
发起方
Simon Fraser University
入组人数
540
试验地点
1
主要终点
Gestational-age adjusted birthweight
状态
已完成
最后更新
6年前

概览

简要总结

The purpose of this study is to use an air filter intervention to evaluate the relationship between particulate matter air pollution exposure during pregnancy and fetal growth. We hypothesize that: 1) portable high efficiency air (HEPA) filters will produce major reductions in home indoor concentrations of particulate matter and 2) pregnant women whose exposures to particulate matter are reduced by this intervention will give birth to children with greater mean body weight for gestational age.

In an extended follow-up of this cohort, we aim to evaluate the relationship between use of portable air purifiers during pregnancy and the growth and development of children from birth to age four years. In particular, the follow-up study will focus on children's physical growth, respiratory symptoms, and behavioral, social and neurocognitive development.

注册库
clinicaltrials.gov
开始日期
2014年1月
结束日期
2019年12月
最后更新
6年前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Ryan Allen

Associate Professor

Simon Fraser University

入排标准

入选标准

  • Adult (\>18 years)
  • Pregnant woman in first trimester (\<14 weeks)
  • Single gestation pregnancy
  • Non-smoker

排除标准

  • Multiple-gestation pregnancy
  • Current smoker
  • Currently operating an air filter in the home
  • Currently living in a ger (traditional Mongolian felt-lined yurt)
  • Plan to give birth outside of a hospital or clinic in Ulaanbaatar

结局指标

主要结局

Gestational-age adjusted birthweight

时间窗: At birth

Birthweight

时间窗: At birth

Gestational age

时间窗: At birth

Head circumference

时间窗: At birth

Small for gestational age

时间窗: At birth

\<10%ile of birth weight for gestational age

Birth length

时间窗: At birth

Birth length

Child body mass index

时间窗: Age 4 years

BMI = weight(kg)/height(m)\^2

Child wheeze

时间窗: Annually from birth to age 4 years

Parent-reported wheeze (ever/never and phenotypes)

Child behavioural development

时间窗: Age 4 years

Sub-scales and composite scores from the Behavior Assessment System for Children, Third Edition (BASC-3)

Child neurocognitive development

时间窗: Age 4 years

Sub-scales and index scores from the Wechsler Preschool and Primary Scale of Intelligence, Fourth Edition (WPPSI-IV)

Child social development

时间窗: Age 4 years

Social Responsiveness Scale, Second Edition (SRS-2) scores

次要结局

  • Blood pressure(At approximately 10, 11, 30 and 31 weeks gestation)
  • C-reactive protein(At approximately 10 and 30 weeks gestation)
  • Stratified Analyses(Various)

研究点 (1)

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