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Food Allergy and Eczema Observational Study

The purpose of the SUNBEAM study is to learn more about factors that put babies and toddlers at higher risk for developing food allergies and eczema. This is an observational study, where we will follow pregnant mothers and their babies from birth to 3 years to learn more about how allergies develop. We are doing this research because there are currently no reliable ways to predict which children will develop food allergies.

Age & Gender

  • 18 years ~ 99 years
  • Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

At the first visit (during pregnancy), we will take measurements of your height and weight. We will take samples from you, including blood, urine, hair, stool, skin, nasal swab and vaginal swab. You will collect a home dust sample and will answer questionnaires related to your health, diet and environment. When your baby is born, we will collect cord blood immediately and other samples (skin, stool) within 1-2 days of delivery. Throughout the study, we will continue to collect samples from you and your child. Samples will include blood, urine, hair, stool, skin, nasal swab, saliva and breast milk. You will collect samples from your home, including dust and water. You will continue to answer questionnaires related to you and your child's health, diet and environment. At each visit, we will take your child's measurements (height and weight). Their skin will be assessed for signs of eczema. Food allergy testing (skin and blood testing) will begin when your child is 5 months old.

Incentives

Compensation is provided., Allergy testing will be performed for children enrolled in this study. Results will be disclosed to you and counseling will be provided if results indicate possible food allergy. Some children may be eligible for an oral food challenge (OFC) to determine allergic status.

In-person visits:
3 visits for Mother (Enrollment Visit, 2 Month Visit, 12 Month Visit); 1 visit for Father (Enrollment Visit; father's participation in the study is optional); 6 visits for Baby (Birth-during hospital stay or within first 7 days of life, 2 Month Visit, 5 Month Visit, 12 Month Visit, 24 Month Visit, 36 Month Visit)
Phone or online visits:
Monthly questionnaires/surveys (can be completed online)
Total length of participation:
Up to 9 months of prenatal observation and 3 years of child observation

Looking for Specific Volunteers

Able to participate:

  • You are pregnant and planning to give birth at UNC
  • You are willing to enroll your baby in the study (after birth)
  • If pregnant with multiples, you are willing to enroll only one baby (selected by randomized birth order)

Not eligible if:

  • You experience a serious pregnancy complication
  • The baby is diagnosed with a major chromosomal anomaly
  • You plan to move away from the study site within the next 3 years
  • You plan to give your baby up for adoption
  • The pregnancy is the result of egg donation

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Clinical and Translational Research Center (CTRC)
Burnett-Womack Building (UNC-Chapel Hill)
160 Dental Cir, Chapel Hill, NC 27514, USA

Secondary Visit Location

OB/GYN Clinic
UNC Health at Weaver Crossing
1181 Weaver Dairy Rd, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Edwin Kim
Medicine-UNCP A Allergy and Immunology

Study Type

Clinical or Medical
Observational

Study Topics

Allergy
Child and Teen Health
Environment
Parents of Children
Pregnancy

IRB Number

20-3253

ClinicalTrials.gov

NCT04798079

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