Systems Biology of Early Atopy
SUNBEAM
3 other identifiers
observational
2,500
1 country
13
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedStudy Start
First participant enrolled
March 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2032
February 19, 2026
February 1, 2026
11 years
March 5, 2021
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Immunoglobulin E (IgE)-Mediated, Immediate-Type Food Allergy
To understand the early life origin and risk factors of child's IgE-mediated, immediate-type food allergy. Based upon clinical assessments and diagnostic criteria for food allergy, in accordance with the Food Allergy Algorithm, per protocol.
From 5 months to 72 months of age
Incidence of Atopic Dermatitis (AD)
To understand the early life origin and risk factors of child's atopic dermatitis (AD). Atopic dermatitis is defined as the following since the last assessment (or since birth for the 2- and 5-month visits): 1. A history of a dry or itchy rash that is (a) either continuous or intermittent lasting at least 4 weeks OR (b) requiring medicated treatment AND 2. The rash was or is present in the skin creases (folds of elbows, behind the knees, fronts of ankles, or around the neck) or on the extensor aspects of the forearms or lower legs or on cheeks or trunk. Any infant fulfilling these criteria but who, on examination by a suitably trained health professional, is deemed to have a different skin disease that explains the above findings will be classified as not having atopic dermatitis.
From 2 months to 72 months of age
Secondary Outcomes (8)
Incidence of Sensitization to Protocol-Specified Foods
From 5 months to 72 months of age
Incidence of Sensitization to Aeroallergens
From 12 months to 72 months of age
Incidence of Recurrent Wheeze
Up to 36 months of age
Incidence of Seasonal Allergic Rhinitis
From 24 to 72 months of age
Incidence of Seasonal Allergic Conjunctivitis
From 24 to 72 months of age
- +3 more secondary outcomes
Eligibility Criteria
The study population will include pregnant women, their offspring from birth until age 3 years or 6 years, and the offspring's biological father. Although biological fathers will be recruited, their enrollment is not required. The women will be recruited from OB/GYN and prenatal clinics and offices. Other than the eligibility criteria listed, women will not be selected by any criteria or characteristics. The intent is to recruit a study population of children of varying risks with regards to the development of allergic diseases. The rationale is to identify risk factors in the population for the development of allergic disease. Selection of pregnant women whose offspring are at an elevated risk of allergic disease would prevent the study of the risk factors used to select the women.
You may qualify if:
- Pregnant Women-
- Pregnant women who meet all of the following criteria are eligible for enrollment as study participants:
- Age 18 years or older
- Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent
- Pregnant at any stage
- Planning to give birth at a study-site designated center
- Agrees to enroll offspring into the study at birth
- In the case of multiple gestation, agrees to enroll only one child who will be selected by randomized birth order
- Biological Fathers-
- Biological fathers who meet all of the following criteria are eligible for enrollment as study participants:
- Age 18 years or older
- Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent
You may not qualify if:
- Pregnant Women-
- Pregnant women who meet any of these criteria are not eligible for enrollment:
- Inability or unwillingness to comply with study protocol
- Serious pregnancy complication (in the judgement of the investigator) prior to enrollment
- Fetus has a major chromosomal anomaly
- Plans to move and would not be available for in-person visits at a study site
- Plans to give up her child for adoption at birth
- Pregnancy is the result of an egg donation
- Infants-
- Infants who meet any of these criteria are not eligible for enrollment:
- Delivered earlier than 34 weeks of gestation
- Sibling already enrolled
- Born with a significant birth defect or medical condition, and in the judgment of the investigators, participation is not in the infant's best interest
- Biological Father-
- \. Biological fathers who are unable or unwilling to comply with the study protocol as it pertains to the biological father's participation are not eligible for enrollment
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Stanford, California, 94040, United States
National Jewish Health
Denver, Colorado, 80206, United States
Northwestern University Feinberg School of Medicine: Dept of Dermatology
Chicago, Illinois, 60611, United States
Johns Hopkins Children's Center, Department of Allergy & Immunology
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital, Translational and Clinical Research Center
Boston, Massachusetts, 02114, United States
Henry Ford Health System, Division of Allergy and Immunology
Detroit, Michigan, 48202, United States
Kravis Children's Hospital, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
Chapel Hill, North Carolina, 27599, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Vanderbilt University Medical Center Department of Pediatrics Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
Nashville, Tennessee, 37232, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792, United States
Related Links
Biospecimen
Environmental and biological samples will be collected, processed, and assayed or stored for current or future use in studies of allergic disease development
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Corinne Keet, MD,MS,PhD
Div.of Pediatric Allergy, Immunology and Rheumatology, Dept. of Pediatrics, Johns Hopkins School of Medicine
- STUDY CHAIR
Scott H. Sicherer, MD
Div. of Pediatric Allergy and Immunology, Jaffe Food Allergy Institute,Dept. of Pediatrics, Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2021
First Posted
March 15, 2021
Study Start
March 18, 2021
Primary Completion (Estimated)
March 1, 2032
Study Completion (Estimated)
March 1, 2032
Last Updated
February 19, 2026
Record last verified: 2026-02