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Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity

2021年9月2日更新者：Pontificia Universidad Catolica de Chile

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

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.

研究概览

地位

完全的

条件

详细说明

The general objectives of this study are:

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.
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.
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.

研究类型

观察性的

注册 (实际的)

240

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 45年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

非概率样本

研究人群

The recruitment of participants was performed in the Sotero del Rio Hospital at Santiago. Women that were obese (BMI>30) or normal weight (BMI<25) at their first antenatal visit were invited to participate in the study at the moment of delivery.

Questionnaires: Information regarding birth outcomes, maternal and paternal history of asthma and allergy, as well as environmental conditions at home (pet ownership, indoor smoking, heating system, and so on) was collected using a questionnaire at the moment of recruitment.

Follow-up questionnaires by phone are completed every 6 months. These questionnaires collect information regarding diagnosis of asthma/allergy and acute respiratory illness, environmental conditions, and relevant confounding variables

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Newborn from obese and nonobese pregnant Obese (BMI>30) or normal weight (BMI<25) women at their first antenatal visit were invited to participate in the study at the moment of delivery at Sotero del Rio Hospital, Santiago. Information regarding birth outcomes, parental history, as well as environmental conditions was collected at recruitment. Follow-up questionnaires by phone were completed every 6 months. Umbilical cord blood samples were collected to measure IL-12, TNF-α, IL-10, IL-4; to evaluate metabolic status; to isolated monocytes and macrophage differentiation; and for DNA methylation status of the promoter regions of the genes coding for TNF-α, IL-12, IL-10, and IL-4Rα. Also, fasting blood samples of the mothers within 48 hours after delivery; and blood samples and skin prick test were collected.

团体/队列

Newborn from obese and nonobese pregnant

Obese (BMI>30) or normal weight (BMI<25) women at their first antenatal visit were invited to participate in the study at the moment of delivery at Sotero del Rio Hospital, Santiago. Information regarding birth outcomes, parental history, as well as environmental conditions was collected at recruitment. Follow-up questionnaires by phone were completed every 6 months. Umbilical cord blood samples were collected to measure IL-12, TNF-α, IL-10, IL-4; to evaluate metabolic status; to isolated monocytes and macrophage differentiation; and for DNA methylation status of the promoter regions of the genes coding for TNF-α, IL-12, IL-10, and IL-4Rα. Also, fasting blood samples of the mothers within 48 hours after delivery; and blood samples and skin prick test were collected.

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Risk of asthma (defined as "positive asthma predictive index" at 36 months of age) 大体时间：36 months of age	36 months of age

次要结果测量

结果测量	大体时间
Allergy status (positive skin prick test) 大体时间：30-36 months of age	30-36 months of age

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pontificia Universidad Catolica de Chile

调查人员

首席研究员：Jose A. Castro-Rodriguez, MD, PhD、Pontificia Universidad Catolica de Chile

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年9月1日

初级完成 (实际的)

2018年4月1日

研究完成 (实际的)

2018年6月1日

研究注册日期

首次提交

2016年9月13日

首先提交符合 QC 标准的

2016年9月15日

首次发布 (估计)

2016年9月16日

研究记录更新

最后更新发布 (实际的)

2021年9月10日

上次提交的符合 QC 标准的更新

2021年9月2日

最后验证

2018年6月1日

Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity