Systems Biology of Early Atopy

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Mar 10, 2021

Keywords

ClinConnect Summary

The "Systems Biology of Early Atopy" clinical trial is focused on understanding how certain factors during pregnancy and early life can lead to allergic diseases, specifically food allergies and atopic dermatitis (a type of skin rash). Researchers aim to collect samples from pregnant women and their babies to identify signs that could indicate a higher risk of developing these conditions. By studying these samples and the environment around them, they hope to discover new ways to predict and possibly prevent allergies in children.

To participate in the study, pregnant women need to be at least 18 years old, able to provide consent, and planning to give birth at a designated study center. Biological fathers can also join if they meet similar age and consent requirements. Participants will be asked to provide biological samples and answer questions about their health and environment over a few years. This research could help improve our understanding of allergies and lead to better ways of managing them for future generations.

Gender

ALL

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