Clinical trial NCT04798079: Systems Biology of Early Atopy
Official title: Systems Biology of Early Atopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allergic Diseases
Food Allergy
Atopic Dermatitis
Keywords: birth cohort
risk factors
systems biology
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Consortium for Food Allergy Research
name: Rho Federal Systems Division, Inc.
First posted: 2021-03-15
Enrollment: 2500
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Immunoglobulin E (IgE)-Mediated, Immediate-Type Food Allergy
timeFrame: From 5 months to 72 months of age
measure: Incidence of Atopic Dermatitis (AD)
timeFrame: From 2 months to 72 months of age
Secondary outcomes:
measure: Incidence of Sensitization to Protocol-Specified Foods
timeFrame: From 5 months to 72 months of age
measure: Incidence of Sensitization to Aeroallergens
timeFrame: From 12 months to 72 months of age
measure: Incidence of Recurrent Wheeze
timeFrame: Up to 36 months of age
measure: Incidence of Seasonal Allergic Rhinitis
timeFrame: From 24 to 72 months of age
measure: Incidence of Seasonal Allergic Conjunctivitis
timeFrame: From 24 to 72 months of age
measure: Incidence of Perennial Allergic Rhinitis
timeFrame: From 24 to 72 months of age
measure: Incidence of Perennial Allergic Conjunctivitis
timeFrame: From 24 to 72 months of age
measure: Incidence of Asthma
timeFrame: 72 months of age
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Stanford
country: United States
facility: Sean N. Parker Center for Allergy & Asthma Research at Stanford University
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins Children's Center, Department of Allergy & Immunology
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital, Translational and Clinical Research Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System, Division of Allergy and Immunology
state: Michigan
city: New York
country: United States
facility: Kravis Children's Hospital, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Department of Pediatrics Division of Pediatric Allergy, Immunology, and Pulmonary Medicine
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: Div.of Pediatric Allergy, Immunology and Rheumatology, Dept. of Pediatrics, Johns Hopkins School of Medicine
name: Corinne Keet, MD,MS,PhD
role: STUDY_CHAIR
affiliation: Div. of Pediatric Allergy and Immunology, Jaffe Food Allergy Institute,Dept. of Pediatrics, Icahn School of Medicine at Mount Sinai
name: Scott H. Sicherer, MD
role: STUDY_CHAIR
References: