Research Center: National Jewish Health
Location: Denver, Colorado
Lead Researcher: Donald Leung MD, Ph.D.
IRB: This study has been reviewed and approved by the Johns Hopkins Medical Center Institutional Review Board

Did you know that nearly 3 percent of infants in the United States develop a food allergy within their first year of life? These alarming statistics highlight the urgent need for a deeper understanding of allergies in young children.
Recognizing the gravity of this issue, researchers at National Jewish Health are leading a groundbreaking study aimed at unraveling the complexities of allergic diseases and their impact on infants both during pregnancy and after birth. Their research endeavors strive to pave the way for a comprehensive understanding of allergic conditions, facilitating easier clinical testing and more effective treatment options in the future.
If you are currently expecting, consider participating in this compensated research study. By joining, you can contribute to advancing researchers’ knowledge and aid in developing strategies to help infants, including your own! Let’s safely navigate the challenges of food allergies in the years to come!

• Participants will receive assistance in safely introducing allergenic foods to their child at no cost.
• Participants will be compensated for participating in this study.
• Participants will receive complimentary skin testing.
• Participants will be contributing valuable information that may benefit children in the future.
• Participants will be helping to advance medical research.

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
• Any information that you provide will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

• Individuals aged 18 and older who are currently pregnant
• Must be willing to enroll your child in this study at birth
• Must be willing to enroll only one child who will be selected by randomized birth order In the case of multiple births
• Must not be planning to move or relocate within 3 years of delivery
• Must not be planning to give up the child for adoption at birth
• Must not be pregnant as the result of an egg donation
• Must be able to attend 6 study visits over approximately 36 months

The study team will explain the research in its entirety but some details are:

• Before the birth, participants will have an enrollment visit at the study site that will include measuring height and weight, providing answers related to medical history, and collecting biological samples like blood, urine, hair, stool, skin swabs, skin tapes, nasal swabs, and vaginal swabs. Participants will be asked to collect environmental samples from their homes such as dust and water. Throughout the study, participants will complete questionnaires related to their and their child’s health, diet, and environment. Participants will be asked to complete some questionnaires over the Internet at home, on their smartphone, tablet, or personal computer. Other questions will be completed at the clinic during study visits.
  At delivery, a blood sample will be collected from the child’s umbilical cord after the cord is detached. At 1–2 days after delivery, before the child leaves the hospital, biological samples (skin swabs, skin tapes, and stool) will be collected. If the skin swab and skin tape samples are not collected at the hospital, study staff may be able to collect them during the child’s first visit to the pediatrician, an unscheduled study visit, or a home visit during the child’s first week of life.
• When the child is 2, 5, 12, 24, and 36 months old, participants will be asked to bring the child to the clinic. At these visits, the study team will collect biological samples. Beginning at 5 months, the visits will also involve allergen skin testing for foods, and at 12, 24, and 36 months, environmental allergens. Participants will also be asked to collect home dust, water samples, and stool samples between visits. Depending on the child’s history of exposure to a food, past food allergy symptoms, and the results of the allergen skin test, the child may have an oral food challenge at one or more visits to confirm the diagnosis of an allergy to that specific food.

National Jewish Health
National Jewish Health is the leading respiratory hospital in the nation. Founded in 1899 as a nonprofit hospital, National Jewish Health today is the only facility in the world dedicated exclusively to groundbreaking medical research and treatment of patients with respiratory, cardiac, immune, and related disorders. Patients and families come to National Jewish Health from around the world to receive cutting-edge, comprehensive, coordinated care.

Please note:
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance.