Systems Biology of Early Atopy (SUNBEAM)
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| ClinicalTrials.gov Identifier: NCT04798079 |
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Recruitment Status :
Recruiting
First Posted : March 15, 2021
Last Update Posted : July 1, 2021
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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 of allergic diseases through age 3 years, 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
| Condition or disease |
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| Allergic Diseases Food Allergy Atopic Dermatitis |
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. 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.
| Study Type : | Observational |
| Estimated Enrollment : | 2500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Systems Biology of Early Atopy |
| Actual Study Start Date : | March 18, 2021 |
| Estimated Primary Completion Date : | June 2027 |
| Estimated Study Completion Date : | June 2027 |
- Incidence of Immunoglobulin E (IgE)-Mediated, Immediate-Type Food Allergy [ Time Frame: From 5 months to 36 months of age ]
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.
- Incidence of Atopic Dermatitis (AD) [ Time Frame: From 2 months to 36 months of age ]
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):
- 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
- 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.
- Incidence of Sensitization to Protocol-Specified Foods [ Time Frame: From 5 months to 36 months of age ]
To understand the early life origin and risk factors of child's food allergy.
Sensitization to food allergens will be assessed using standard diagnostic methods: serum immunoglobulin E (IgE) testing and skin prick testing.
- Incidence of Sensitization to Aeroallergens [ Time Frame: From12 months to 36 months of age ]
To understand the early life origin and risk factors of child's sensitization to aeroallergens, a risk factor for the development and severity of asthma.
Sensitization to aeroallergens will be assessed using standard diagnostic methods: serum immunoglobulin E (IgE) testing and skin prick testing.
- Incidence of Recurrent Wheeze [ Time Frame: Up to 36 months of age ]
To understand the early life origin and risk factors of child's recurrent wheezing.
Recurrent wheeze, assessed at age 3 years, will be defined as at least two episodes of wheezing during the first three years of life, with at least one episode between the ages of 24 and 36 months
- Incidence of Seasonal Allergic Rhinitis [ Time Frame: From 24 to 36 months of age ]
To understand the early life origin and risk factors of child's seasonal allergic rhinitis, a seasonal allergic reaction to pollen.
Defined by diagnostic criteria established for the Inner-City Asthma Consortium, per protocol.
- Incidence of Seasonal Allergic Conjunctivitis [ Time Frame: From 24 to 36 months of age ]
To understand the early life origin and risk factors of child's seasonal allergic conjunctivitis, a form of eye allergy.
Defined by diagnostic criteria established for the Inner-City Asthma Consortium, per protocol.
- Incidence of Perennial Allergic Rhinitis [ Time Frame: From 24 to 36 months of age ]
To understand the early life origin and risk factors of child's perennial allergic rhinitis, characterized by nasal symptoms such as sneezing and runny nose that are present year round.
Defined by diagnostic criteria established for the Inner-City Asthma Consortium, per protocol.
- Incidence of Perennial Allergic Conjunctivitis [ Time Frame: From 24 to 36 months of age ]
To understand the early life origin and risk factors of child's perennial allergic rhinitis, characterized by nasal symptoms such as sneezing and runny nose that are present year round.
Defined by diagnostic criteria established for the Inner-City Asthma Consortium, per protocol.
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
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
Exclusion Criteria:
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-
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:
- 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
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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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04798079
| United States, Arkansas | |
| Arkansas Children's Hospital | Recruiting |
| Little Rock, Arkansas, United States, 72202 | |
| Contact: Cassandra Thomas 501-364-5178 ThomasC1@archildrens.org | |
| Principal Investigator: Stacie M. Jones, MD | |
| United States, California | |
| Sean N. Parker Center for Allergy & Asthma Research at Stanford University | Recruiting |
| Stanford, California, United States, 94040 | |
| Contact: Melanie Shojinaga 650-521-7237 snpallergy@stanford.edu | |
| Principal Investigator: R. Sharon Chinthrajah, MD | |
| United States, Colorado | |
| National Jewish Health | Recruiting |
| Denver, Colorado, United States, 80206 | |
| Contact: Susan Leung, RN 303-398-1549 leungs@NJHealth.org | |
| Principal Investigator: Donald Y.M. Leung, PhD, MD | |
| United States, Illinois | |
| Northwestern Medicine, Department of Dermatology | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Stephanie Rangel, PhD 312-503-5942 stephanie.rangel@northwestern.edu | |
| Principal Investigator: Amy S. Paller, MD | |
| United States, Maryland | |
| Johns Hopkins Children's Center, Department of Allergy & Immunology | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Kim Mudd, RN 410-502-1711 kmudd2@jhmi.edu | |
| Principal Investigator: Corinne Keet, MD,MS,PhD | |
| United States, Massachusetts | |
| Massachusetts General Hospital, Translational and Clinical Research Center | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Lucia Costanza 575-779-2127 lcostanza@mgh.harvard.edu | |
| Principal Investigator: Wayne G. Shreffler, MD, PhD | |
| United States, Michigan | |
| Henry Ford Health System, Division of Allergy and Immunology | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Laurie B. Nightengale 541-213-0768 Lmarsha6@hfhs.org | |
| Principal Investigator: Christine C. Johnson, PhD, MPH | |
| United States, New York | |
| Kravis Children's Hospital, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Beth Mattucci 212-241-6577 beth.mattucci@mssm.edu | |
| Principal Investigator: Scott H. Sicherer, MD | |
| United States, North Carolina | |
| North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Sarah Bennick, MSN,APRN,CPNP 919-962-4409 sbennick@email.unc.edu | |
| Sub-Investigator: Edwin H. Kim, MD, MS | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Pamela Groh, RN 513-383-6016 Pam.groh@cchmc.org | |
| Principal Investigator: Gurjit Khurana Hershey, MD, PhD | |
| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Daisy Tran Vita 832-824-3640 dxtran1@texaschildrens.org | |
| Principal Investigator: Carla M. Davis, MD | |
| United States, Wisconsin | |
| University of Wisconsin School of Medicine and Public Health | Recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Contact: Gina Crisafi, BS 608-262-5240 gmc@medicine.wisc.edu | |
| Principal Investigator: James Gern, MD | |
| 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 |
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT04798079 |
| Other Study ID Numbers: |
DAIT CoFAR-12 NIAID CRMS ID#: ( Other Identifier: 38710 ) UM2AI130836 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 15, 2021 Key Record Dates |
| Last Update Posted: | July 1, 2021 |
| Last Verified: | June 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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birth cohort risk factors systems biology |
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Dermatitis, Atopic Dermatitis Food Hypersensitivity Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |