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临床试验/NCT03352960
NCT03352960进行中(未招募)不适用

Environment and Childhood Project Based on a Multicentric Mother-child Cohort of Spain

Basque Health Service1 个研究点 分布在 1 个国家目标入组 2,957 人开始时间: 1997年1月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
2,957
试验地点
1
主要终点
Development

研究概览

简要总结

INMA - INfancia y Medio Ambiente [Environment and Childhood] Project is a research network of several Spanish groups that created a project with the aim to study the paper of the more relevant environmental pollutants in the air, water and diet during the pregnancy and beginning of life, and their effects in the growth and development.

The INMA Project is based on the experience acquired by groups that studied several cohorts with different objectives: the cohort of Riera d'Ebre (n=102), an area with high levels of organochlorine compounds and mercury, evaluated the relationship between these exposures and the neurological development of the children; the cohort of Menorca (n=492), studied the relationship between the early exposure to irritating of the air and allergens with the development of allergy and asthma; and the cohort of Granada (n=668), that studied the incidence of reproductive disorders in men in relation to the exposure to endocrine disruptors.

Based on the experience of these previous cohorts, other 4 new cohorts were designed to evaluate the impact of environmental exposures in children's health: Valencia (n=787), Sabadell (n=622), Asturias (n=485) and Gipuzkoa (n=612), that followed the same protocol. The population of the study are pregnant women of the general population who lived in each area of study (Ribera d' Ebre, Menorca, Granada, Valencia, Sabadell, Asturias, and Gipuzkoa and their children. Each cohort had different periods and types from recruitment. In the cohorts of Ribera d'Ebre and Granada, the mothers were recruited during the admission to the hospital at the moment of the childbirth. In Ribera d'Ebre, the recruitment was between March 1997 and December 1999, whereas in Granada it was between October 2000 and July 2002. In Menorca, all the eligible women who went to the prenatal visit in some of the sanitary centres of the island (private or public) were invited to participate in the study, and the recruitment lasted a year starting in July 1997. In the 4 new cohorts the recruitment took place during the first prenatal visit (between weeks 10 and 13 of gestation) in the public hospital of reference or in the health centre of the area. The periods of recruitment went from February 2004 to June 2005 in Valencia, from July 2004 to July 2006 and May 2007 to July 2007 (there was an additional round of recruitment) in Sabadell, from May 2004 to June 2007 in Asturias, and from April 2006 to January 2008 in Gipuzkoa.

研究设计

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

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To belong to the study area (specific of each cohort). To be minimum 16 years. To have a unique pregnancy To give birth in the reference hospital

排除标准

  • To have followed any program of assisted reproduction To have communication problems

结局指标

主要结局

Development

时间窗: 4 years

BMI (kg/m\^2)

次要结局

未报告次要终点

研究者

发起方
Basque Health Service
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Jesus Ibarluzea

Principal Investigator

Basque Health Service

研究点 (1)

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