Childhood Allergy and the Neonatal Environment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 499
- 试验地点
- 4
- 主要终点
- Number of children with recurrent wheeze
研究概览
简要总结
The purpose of this research study is to study the relationship between childhood asthma, allergies, and early-life environmental factors that may cause childhood asthma and allergies. Previous birth cohort studies have found early-life environmental factors such as allergies, pollutants, viruses and bacteria have all contributed to the development of asthma and allergies. Investigators are doing this research because there continues to be a strong need to understand the root causes of asthma and allergies. The CANOE study is an observational cohort study, which means investigators are not asking participants or participant's child to change their medications and investigators will not be giving participants or participant's child a study drug.
详细描述
The CANOE study will provide an opportunity to collect novel longitudinal samples not available from the current CANOE birth cohorts, as well as enhanced and standardized environmental sampling in early life. One of the main goals of this study is to gather data and specimens, beginning in the prenatal periods, that will assess environmental exposures to toxins and microbes, and host characteristics including genetics, epigenetics, gene expression, the proteome and metabolome, microbial colonization and viral respiratory infections. The main study outcomes will be important interim conditions (e.g., recurrent wheeze, early multiple sensitization) that are highly associated with the development of asthma. Additional outcomes (perinatal outcomes, growth, neurocognitive development) will be collected as part of the collaborative Environmental Influences on Child Health Outcomes (ECHO)-wide Cohort Data Collection Protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of or concurrent asthma or allergic rhinitis (hay fever) in either biologic parent or sibling (at least one shared biological parent) by parental report. The presence of paternal or sibling allergy or asthma will be ascertained by maternal report.
- •Maternal age greater than or equal to 18 years at the time of study enrollment.
排除标准
- •Maternal HIV infection at time of delivery.
- •Plans for the family to move out of the geographic area during the period of the study.
- •Does not speak English.
- •Current maternal use of progesterone during pregnancy to prevent preterm birth.
- •Progesterone use is only an exclusion if currently being taken at time of enrollment for preterm birth. Previous use to prevent preterm birth or use at any time for other indications is allowed.
- •Pregnancy is a result of an embryo donor (egg and sperm donor pregnancies are permitted).
- •Past or current medical problems or findings from physical examination or laboratory testing which, in the opinion of the investigator or designee, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
结局指标
主要结局
Number of children with recurrent wheeze
时间窗: 3 years
Number of children with recurrent wheezing will be reported. Recurrent wheeze, defined as at least 2 episodes of wheeze with one occurring in the last 12 months of study participation for children between 2 and 3 years of age.
Number of children with early aeroallergen sensitization
时间窗: 2 years
Number of children with early aeroallergen sensitization will be reported. Early aeroallergen sensitization, defined as sensitization to at least one aeroallergens by age 2 years.
Number of children diagnosed with asthma
时间窗: 4 years
Number of children who diagnosed, either by a doctor or self-report, at age 6 or 7 years.
次要结局
- Number of children with Atopic dermatitis (AD)(3 years)
- Number of children with food allergies(3 years)
- Lung function(4 years)