Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities - A Pilot Study
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of the study is to see whether early feeding of potentially allergic foods can be increased with educational materials alone or with educational materials and additional in-person support opportunities. This study will help guide what types of support pediatricians and allergists give to new parents.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 4 months
Maximum Age: 11 months
Healthy Volunteers: t
View:
• Born term (37 weeks - 41 weeks gestation)
• Infants with or without a family history of allergic disease
• Infants with or without mild to moderate eczema
• Infants who have not yet started consuming known allergenic foods (excluding cow's milk or soy if it is in their infant formula)
• Parent or caregiver ≥ 18 years of age
• Agree to infant blood draw (two)
• Agree to participate in the 6 month research study
Locations
United States
California
Stanford University
RECRUITING
Stanford
Time Frame
Start Date: 2026-06-30
Estimated Completion Date: 2028-02
Participants
Target number of participants: 92
Treatments
No_intervention: Standard of Care
The participants in the standard-of-care (SOC) group will be provided with three sets of nonsynchronous educational materials or modules to learn about early introduction of known food allergens and infant nutrition. A quiz will follow each educational module. Participants have the option to come to the research clinic to introduce known allergenic foods under clinician supervision. If none of the 9 most common known allergenic foods in the US (peanut, tree nut, hen's egg, cow's milk, soy, sesame, finned fish, shell fish, wheat) have been fed to the infant by the end of 3 months study enrollment the participant will be required to return to the research clinic for an introductory feeding of a known allergenic food of their choice under clinical supervision. The oral feeding will last approximately 1 hour.
Experimental: Enhanced Educational Opportunities
The participants in the experimental group will be provided with the same three sets of educational materials or modules as the SOC group to learn about early introduction of food allergens and infant nutrition. Experimental participants will also attend 3 in-person or live video conferencing education sessions paired with each of the 3 educational modules. The educational classes last 30 minutes and are meant to enhance the information and allow opportunities for questions. The same quiz as the SOC group will follow each educational module. This arm will be required to return to the research clinic for at least one introductory feeding of a known allergenic food (peanut, tree nut, egg, milk, soy, sesame, finned fish, shell fish, wheat) during the first three months of the study under clinician supervision. The oral feeding will last approximately 1 hour.
Related Therapeutic Areas
Sponsors
Leads: Stanford University