Systems Biology of Early Atopy (SUNBEAM)

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Enrolling

Conditions: Atopic Dermatitis; Food Allergy; Allergic Diseases

Study type: Observational

Funder types: Industry; Other; NIH

Identifiers

NCT04798079

UM2AI130836 (U.S. NIH Grant/Contract)

DAIT CoFAR-12

NIAID CRMS ID#: (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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