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临床试验/NCT02903134
NCT02903134已完成不适用

Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity: An Epigenetic-mediated Programming of Immune Function

Pontificia Universidad Catolica de Chile0 个研究点目标入组 240 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
240
主要终点
Risk of asthma (defined as "positive asthma predictive index" at 36 months of age)

研究概览

简要总结

This study seeks a better understanding of the pathogenesis of asthma in early life. The aim of this project is to determine whether the offspring of obese mothers at 3 years of life have increased the risk of asthma compared to children whose mothers were not obese and whether this increased risk is associated with a programming altered immune reactivity at birth.

详细描述

The general objectives of this study are:

  1. To determine whether the increased risk of asthma in children born from a pre-pregnant obese mother can be observed at 3 years of life and whether this increased risk associated with altered plasma levels of immune mediators at birth.
  2. To explore in children born from pre-pregnant obese mother whether monocyte physiology and M1-M2 polarization present an altered response and expression of asthma-related immune-modulations at birth.
  3. To study in neonates born from pre-pregnant obese mother whether the in vitro expression of TNFα, IL12, IL-10 and IL-4Rα in monocytes associates with changes in the DNA methylation status in the promoter regions of those genes.

The study is performed in accordance with the Helsinki Declaration, and the study protocol was accepted by Institutional Review Boards at School of Medicine of the Pontificia Universidad Católica de Chile.

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
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who receive care in any of the 12 public health care centers in La Florida and Puente Alto and give birth in the Sotero del Río Hospital.
  • Singleton pregnancy of fewer than 14 weeks of gestation at the first antenatal visit.
  • 18 years or older

排除标准

  • Pregnant women with overweight (BMI 25-30) before 14 weeks.
  • Women that have a premature birth, cardio-respiratory disorder or neurological defects of the neonate.
  • Women that develop gestational diabetes and hypertension during pregnancy

结局指标

主要结局

Risk of asthma (defined as "positive asthma predictive index" at 36 months of age)

时间窗: 36 months of age

次要结局

  • Allergy status (positive skin prick test)(30-36 months of age)

研究者

申办方类型
Other
责任方
Sponsor

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