Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2500 participants
OBSERVATIONAL
2021-03-18
2032-03-31
Brief Summary
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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
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Pregnant women who meet all of the following criteria are eligible for enrollment as study participants:
1. Age 18 years or older
2. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent
3. Pregnant at any stage
4. Planning to give birth at a study-site designated center
5. Agrees to enroll offspring into the study at birth
6. 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:
1. Age 18 years or older
2. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent
Exclusion Criteria
Pregnant women who meet any of these criteria are not eligible for enrollment:
1. Inability or unwillingness to comply with study protocol
2. Serious pregnancy complication (in the judgement of the investigator) prior to enrollment
3. Fetus has a major chromosomal anomaly
4. Plans to move and would not be available for in-person visits at a study site
5. Plans to give up her child for adoption at birth
6. Pregnancy is the result of an egg donation
Infants-
Infants who meet any of these criteria are not eligible for enrollment:
1. Delivered earlier than 34 weeks of gestation
2. Sibling already enrolled
3. 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-
1\. 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
----Note Regarding Legal Guardians who are not the Biological Parents:
1. At screening for enrollment of either the mother or the child, if the biological mother intends to give the infant up for adoption, neither the mother nor the child are eligible for enrollment
2. If the biological mother gives up legal guardianship of the child during the child's follow-up period, the child may remain enrolled as long as the new legal guardian:
* Agrees to meet the child's study requirements, and
* Provides written informed consent for the child's continued participation.
3. Throughout the protocol where it refers to the mother, father, or parent answering questionnaires about the child or collecting samples from the child and the child's primary home, the legal guardian who provides consent for the child's participation may complete those procedures
0 Years
ALL
Yes
Sponsors
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Consortium for Food Allergy Research
UNKNOWN
Rho Federal Systems Division, Inc.
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Corinne Keet, MD,MS,PhD
Role: STUDY_CHAIR
Div.of Pediatric Allergy, Immunology and Rheumatology, Dept. of Pediatrics, Johns Hopkins School of Medicine
Scott H. Sicherer, MD
Role: STUDY_CHAIR
Div. of Pediatric Allergy and Immunology, Jaffe Food Allergy Institute,Dept. of Pediatrics, Icahn School of Medicine at Mount Sinai
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Stanford, California, United States
National Jewish Health
Denver, Colorado, United States
Johns Hopkins Children's Center, Department of Allergy & Immunology
Baltimore, Maryland, United States
Massachusetts General Hospital, Translational and Clinical Research Center
Boston, Massachusetts, United States
Henry Ford Health System, Division of Allergy and Immunology
Detroit, Michigan, United States
Kravis Children's Hospital, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai
New York, New York, United States
North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Vanderbilt University Medical Center Department of Pediatrics Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Countries
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Facility Contacts
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Related Links
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National Institute of Allergy and Infectious Diseases (NIAID)
NIAID Division of Allergy, Immunology, and Transplantation
Other Identifiers
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NIAID CRMS ID#:
Identifier Type: OTHER
Identifier Source: secondary_id
DAIT CoFAR-12
Identifier Type: -
Identifier Source: org_study_id
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