NCT04798079

Systems Biology of Early Atopy

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 0 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to establish a birth cohort that collects prenatal and early life biosamples and environmental samples and rigorously phenotypes young children for food allergy and Atopic Dermatitis (AD) to identify prenatal and early life markers of high risk for food allergy and AD, as well as biological pathways (endotypes) that result in these conditions. Primary Objectives: * To study the role and interrelationships of established and novel clinical, environmental, biological, and genetic prenatal and early-life factors in the development and course of allergic diseases through age 3 years (or 6 years for those who choose to continue participation into SUNBEAM II), with an emphasis on atopic dermatitis and food allergy * To apply systems biology to identify mechanisms and biomarkers underlying the development of food allergy, atopic dermatitis, and their endotypes * To collect, process, and assay or store environmental and biological samples for current and future use in the study of allergic disease development

Detailed description

This is a prospective cohort study in which pregnant women (at any stage of pregnancy), the offspring's biologic father, and the offspring will be enrolled at study sites and the offspring will be observed from birth to age 3 years. Families will be offered the opportunity for the child participant to continue SUNBEAM through age 6. The enrollment goal is at least 2500 pregnant women who agree to enroll their offspring at birth. Enrollment of biological fathers will be attempted; however, enrollment of the mother or child is not dependent on enrollment of the biological father. During the study, biological and environmental samples and questionnaire information will be collected from the parents and the children, and the children will be assessed for allergic diseases at clinic visits at ages 2, 5, 12, 24, and 36 months and for those who opt to continue participation, at 48, 60, and 72 months.

Conditions

• Allergic Diseases
• Food Allergy
• Atopic Dermatitis

Timeline

• Start date: 2021-03-18
• Primary completion: 2032-03-01
• Completion: 2032-03-01
• First posted: 2021-03-15
• Last updated: 2026-02-19

Locations

13 sites across 1 country: United States