Systems Biology of Early Atopy

Description

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

Conditions

Allergic Diseases, Food Allergy, Atopic Dermatitis

Talk to us

Study Overview

On this page

Study Details

Study overview

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

Systems Biology of Early Atopy

Systems Biology of Early Atopy

Condition
Allergic Diseases
Intervention / Treatment

-

Contacts and Locations

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

Stanford

Sean N. Parker Center for Allergy & Asthma Research at Stanford University, Stanford, California, United States, 94040

Denver

National Jewish Health, Denver, Colorado, United States, 80206

Baltimore

Johns Hopkins Children's Center, Department of Allergy & Immunology, Baltimore, Maryland, United States, 21287

Boston

Massachusetts General Hospital, Translational and Clinical Research Center, Boston, Massachusetts, United States, 02114

Detroit

Henry Ford Health System, Division of Allergy and Immunology, Detroit, Michigan, United States, 48202

New York

Kravis Children's Hospital, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Chapel Hill

North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology, Chapel Hill, North Carolina, United States, 27599

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Nashville

Vanderbilt University Medical Center Department of Pediatrics Division of Pediatric Allergy, Immunology, and Pulmonary Medicine, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Ages Eligible for Study

0 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

National Institute of Allergy and Infectious Diseases (NIAID),

Corinne Keet, MD,MS,PhD, STUDY_CHAIR, Div.of Pediatric Allergy, Immunology and Rheumatology, Dept. of Pediatrics, Johns Hopkins School of Medicine

Scott H. Sicherer, MD, STUDY_CHAIR, Div. of Pediatric Allergy and Immunology, Jaffe Food Allergy Institute,Dept. of Pediatrics, Icahn School of Medicine at Mount Sinai

Study Record Dates

2032-03