Systems Biology of Early Atopy

Recruiting

• Conditions: Atopic Dermatitis; Food Allergy; Allergic Diseases

• Registration Number: NCT04798079
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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 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

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. 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 Timeline

• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-15
• Study Start: 2021-03-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2028-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Atopic Dermatitis (AD)	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): 1. 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; 2. 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 Immunoglobulin E (IgE)-Mediated, Immediate-Type Food Allergy	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Seasonal Allergic Conjunctivitis	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	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	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 Sensitization to Protocol-Specified Foods	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	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	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	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.

Trial Locations

Locations (12)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

University of Wisconsin School of Medicine and Public Health; 🇺🇸 Madison, Wisconsin, United States

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

Johns Hopkins Children's Center, Department of Allergy & Immunology; 🇺🇸 Baltimore, Maryland, United States

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

Sean N. Parker Center for Allergy & Asthma Research at Stanford University; 🇺🇸 Stanford, California, United States

North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology; 🇺🇸 Chapel Hill, North Carolina, United States

Kravis Children's Hospital, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Vanderbilt University Medical Center Department of Pediatrics Division of Pediatric Allergy, Immunology, and Pulmonary Medicine; 🇺🇸 Nashville, Tennessee, United States

National Jewish Health; 🇺🇸 Denver, Colorado, United States

Henry Ford Health System, Division of Allergy and Immunology; 🇺🇸 Detroit, Michigan, United States

Massachusetts General Hospital, Translational and Clinical Research Center; 🇺🇸 Boston, Massachusetts, United States