Development of IgE Autoantibodies in Newborns With Atopic Dermatitis (DIANA) Birth Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Prevalence of IgE autoantibodies against skin epitopes in newborns
研究概览
简要总结
Previous research has shown that some patients with atopic eczema have specific self-reactive antibodies, known as IgE autoantibodies, that react to their own skin cells, referred to as "self-reactive antibodies" or "autoantibodies". It is not yet known when and how these self-reactive antibodies develop, so this is what we aim to investigate.
This study aims to examine the presence of self-reactive antibodies at birth. In other words, the investigators want to study the earliest stage of developing antibodies that target the body's own skin cells. Additionally, factors that contribute to the development of these self-reactive antibodies will be explored as well as the correlation with the development of atopic eczema.
The study will involve newborns who are at an increased risk of developing atopic eczema due to a family history of asthma, hay fever, or atopic eczema. There will also be a control group of newborns without these characteristics. The study's approach is to examine a portion of the umbilical cord blood, which is routinely collected after birth, to investigate self-reactive antibodies. The goal is to determine whether these self-reactive antibodies are linked to the development of atopic eczema in the first two years of life. For this purpose, follow-ups will be conducted at the ages of 6, 12, and 24 months.
This study will contribute to an increased understanding of the prevalence of self-reactive antibodies and the factors influencing their development. Moreover, the study will determine whether these antibodies play a role in the prevention of and/or serve as predictive factors for the development of atopic eczema.
详细描述
IgE autoantibodies against self-peptides in the skin have been identified in a subgroup of patients AD. These autoantibodies are present in subjects with comorbid allergic diseases in particular and are usually absent in healthy individuals, suggesting a link between IgE autoreactivity and allergic disease burden (Kortekaas Krohn I, et al. Allergy 2023). A prevalence of 15% of IgE autoantibodies was reported in infants younger than one year with AD, proving the development of IgE autoantibodies already early in life (Mothes N, et al. J Allergy Clin Immunol 2005).
The Development of IgE Autoantibodies in Newborns with (a high-risk of) Atopic dermatitis (DIANA) study is a large birth cohort, including a well-characterized and demographically diverse population with extensive early-life data of the infants and their parents. The DIANA birth cohort has an interdisciplinary design with a follow-up until the age of two years, enabling detailed monitoring of AD and other conditions.
In the present study, it is hypothesized that hereditary factors, lifestyle, and the environment can influence the development of self-reactive antibodies. To assess hereditary factors, a one-time blood sample will be taken from the biological mother and father, focusing solely on self-reactive antibodies and inflammatory substances. In addition, non-invasive and painless skin barrier measurements will be performed to study the skin barrier function. Environmental factors are investigated through questionnaires and swabs are being taken from the skin or stool to study the composition of the microbes.
The primary objective is:
To determine the presence of self-reactive antibodies at birth or early development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborns who are planned to be born at the maternity ward of UZ Brussel with the following criteria:
- •400 newborns with high-risk for AD-development (at least 1 parent or sibling with physician diagnosed atopic dermatitis AND/OR asthma AND/OR allergic rhinitis)
- •100 newborns with low-risk for AD-development (no parents or siblings with history of atopic dermatitis AND/OR asthma AND/OR allergic rhinitis)
排除标准
- •Newborns not born at the maternity ward of UZ Brussel
- •Parents with a poor understanding of Dutch, French or English
- •Newborns who are admitted post-partum to the neonatal intensive care unit (gestational age <34 weeks) or with medical complications
- •Newborns with severe genetic abnormalities/birth defects
- •Newborns whose parents will not be able to attend the study visits for a period of 2 years (location, working hours)
结局指标
主要结局
Prevalence of IgE autoantibodies against skin epitopes in newborns
时间窗: From enrollment to study visit 2 after birth.
The prevalence (or first developmental stages) of IgE autoantibodies directed against keratinocyte-derived proteins in newborns (with high risk of atopic dermatitis).
次要结局
- Investigation of the hereditary factor in case IgE autoantibodies present(From enrollment to visit 5 at 24 months.)
- Characterization of leukocytes in infants(Through study completion, an average of 2 years)
- Correlation between the presence of IgE autoantibodies and the development of atopic dermatitis(From visit 2 (after birth) to visit 5 at 24 months of age.)
- Correlation of IgE autoantibodies with IgE levels in serum(From visit 2 after birth to visit 5 at 24 months of age.)
研究者
Inge Kortekaas
Assistant professor
Universitair Ziekenhuis Brussel