Systems Biology of Early Atopy

Atopic Dermatitis Clinical Trial

— SUNBEAM  

Official title:

Systems Biology of Early Atopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04798079
• Other study ID #: DAIT CoFAR-12
• Secondary ID: NIAID CRMS ID#:U
• Status: Recruiting
• Start date: March 18, 2021
• Est. completion date: September 2028

Study information

• Verified date: April 2024
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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

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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: September 2028
• Est. primary completion date: September 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years and older

Eligibility

Inclusion Criteria:

Pregnant Women-

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-

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

Related Conditions & MeSH terms

• Allergic Diseases
• Atopic Dermatitis
• Dermatitis
• Food Allergy
• Food Hypersensitivity

Locations

Country	Name	City	State
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	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	National Jewish Health	Denver	Colorado
United States	Henry Ford Health System, Division of Allergy and Immunology	Detroit	Michigan
United States	Texas Children's Hospital	Houston	Texas
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin
United States	Vanderbilt University Medical Center Department of Pediatrics Division of Pediatric Allergy, Immunology, and Pulmonary Medicine	Nashville	Tennessee
United States	Kravis Children's Hospital, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai	New York	New York
United States	Sean N. Parker Center for Allergy & Asthma Research at Stanford University	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Consortium for Food Allergy Research, Rho Federal Systems Division, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 36 months of age
Primary	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): 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.	From 2 months to 36 months of age
Secondary	Incidence of Sensitization to Protocol-Specified Foods	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.	From 5 months to 36 months of age
Secondary	Incidence of Sensitization to Aeroallergens	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.	From12 months to 36 months of age
Secondary	Incidence of Recurrent Wheeze	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	Up to 36 months of age
Secondary	Incidence of Seasonal Allergic Rhinitis	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.	From 24 to 36 months of age
Secondary	Incidence of Seasonal Allergic Conjunctivitis	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.	From 24 to 36 months of age
Secondary	Incidence of Perennial Allergic Rhinitis	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.	From 24 to 36 months of age
Secondary	Incidence of Perennial Allergic Conjunctivitis	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.	From 24 to 36 months of age