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临床试验/NCT05002023
NCT05002023招募中不适用

PRINCE - PRenatal Identification of Childrens HEalth

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2011年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Types of allergic diseases in childhood

研究概览

简要总结

In the PRINCE study we recruit healthy but also diseased pregnant women into a cohort study, followed by the assessment of children´s health and immunity at birth and during the first 10 years of life. This unique cohort allows for testing the impact of prenatal challenges on children´s health.

详细描述

Children´s Health is critically dependent of the prenatal well-being of the mother, and a number of observational studies have identified an impaired immunity in children upon prenatal challenges, such as stress perception, medication, nutrition or infection. However, concerted, in-depth studies assessing how such prenatal challenges may alter fetal development and subsequently children´s health in humans are largely lacking. In the present project, we address this limitation by recruiting healthy, but also diseased pregnant women into a cohort study, followed up by the assessment of children´s health and immunity at birth and during the first ten years of life.

Study participants are recruited early in the first trimester (12-15 weeks of gestation). By means of data security all participants receive a study number. Data processing into the data base (Redcap) is performed under this pseudonym.

During the first visit, the study team explains the enrollment conditions and the participants are asked to give their consent. Study visits include the documentation of clinically important conditions, sonographic examination of the fetus, assessment of mother´s height and weight as well as blood collection (21 ml) of the mother. Additionally we document any kind of medication-intake and nutrition data, and the participants are asked to fill in a psychometric questionnaire. Study visits are scheduled according to the week of gestation, i.e. around 13th, 20th (ultrasound only), 24th, 28th, 34th week. If women give birth in our clinic, we are able to collect cord blood after birth.

Blood samples are processed immediately and stored in our laboratory under Biobank-conditions.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women
  • >18 years of age
  • able to understand and sign the papers of consent
  • singleton pregnancy

排除标准

  • <18 years of age
  • unable to give consent
  • multiple pregnancy
  • nicotine abuse
  • fetal aberration

结局指标

主要结局

Types of allergic diseases in childhood

时间窗: 10 years follow up

The different types of allergic diseases are assessed by a yearly questionnaire, a pediatric examination and lung function testing of the child aged 5 and 9 1/2 years, as well as analysing blood samples of the child aged 5 and 9 1/2 years. Main allergies we measure are inhalation allergens and infant food.

次要结局

  • influences during pregnancy that potentially affect children´s health(10 years follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anke Diemert

PD Dr. med. Anke Diemert

Universitätsklinikum Hamburg-Eppendorf

研究点 (1)

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