Understanding early life factors in allergic diseases
Systems Biology of Early Atopy
National Institute of Allergy and Infectious Diseases (NIAID) · NCT04798079
This study looks at how things during pregnancy and early childhood might affect the risk of food allergies and skin conditions in kids up to age 6.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 0 Years and up |
| Sex | All |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) (nih) |
| Locations | 12 sites (Little Rock, Arkansas and 11 other locations) |
| Trial ID | NCT04798079 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a birth cohort by enrolling pregnant women and their biological fathers to collect prenatal and early life biosamples and environmental samples. The study will rigorously phenotype young children for food allergies and atopic dermatitis, focusing on identifying prenatal and early life markers that indicate a high risk for these conditions. Participants will be observed from birth to age 3 years, with the option to continue participation until age 6, while collecting various biological and environmental data to explore the mechanisms and biomarkers associated with allergic diseases.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 18 or older who are planning to give birth at a designated study site and are willing to enroll their offspring.
Not a fit: Patients who are not pregnant or those who do not plan to give birth at a study site will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early identification and prevention strategies for food allergies and atopic dermatitis in children.
How similar studies have performed: Other studies have shown success in identifying risk factors for allergic diseases, but this approach utilizing systems biology in a birth cohort is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas and 11 other locations
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (RECRUITING)
- Sean N. Parker Center for Allergy & Asthma Research at Stanford University — Stanford, California, United States (ACTIVE_NOT_RECRUITING)
- National Jewish Health — Denver, Colorado, United States (RECRUITING)
- Johns Hopkins Children's Center, Department of Allergy & Immunology — Baltimore, Maryland, United States (RECRUITING)
- Massachusetts General Hospital, Translational and Clinical Research Center — Boston, Massachusetts, United States (ACTIVE_NOT_RECRUITING)
- Henry Ford Health System, Division of Allergy and Immunology — Detroit, Michigan, United States (ACTIVE_NOT_RECRUITING)
- Kravis Children's Hospital, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
- North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology — Chapel Hill, North Carolina, United States (ACTIVE_NOT_RECRUITING)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (RECRUITING)
- Vanderbilt University Medical Center Department of Pediatrics Division of Pediatric Allergy, Immunology, and Pulmonary Medicine — Nashville, Tennessee, United States (ACTIVE_NOT_RECRUITING)
- Texas Children's Hospital — Houston, Texas, United States (RECRUITING)
- University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States (ACTIVE_NOT_RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Allergic Diseases, Food Allergy, Atopic Dermatitis, birth cohort, risk factors, systems biology