Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities in Infants
ConditionFood Allergy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-11
SponsorStanford University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Infants with a physician confirmed food allergy
Infants who do not eat fully by an oral route such as tube-fed or tube-supplemented babies
Infants with developmental delay
Infants with severe eczema
Trial design
Design model
Parallel
Treatments tested in this trial
Education and Opportunities on Early Introduction
BehavioralThe participant will receive and review three educational modules on the basics of food allergy, food allergy reactions, food allergen introduction, feeding safety and readiness, fiber, fermented food, ultra processed foods, diet diversity, and advancing food textures in the infant diet. The educational sessions will take approximately one hour to review every month for three months.
Clinician Supervised Feeding of Known Allergenic Food
BehavioralClinician supervised feeding introduction of a known allergenic food (hen's egg, cow's milk, peanut, tree nuts, soy, wheat, fin fish, shellfish, and sesame) to the infant at least one time during the 6 month enrollment. The feeding is required for the intervention group and optional for the standard-of-care (SOC) group. Participants in the SOC group who do not introduce any known allergenic foods at home into the infant's diet by the end of 3 months enrollment will be required to return to the clinic for a clinician supervised feeding of a known allergenic food of their choice. The clinic feeding will last approximately 1 hour.
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: Enhanced Educational OpportunitiesExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Compare the infant age at which allergenic foods were introduced
Compare the number of known allergenic foods introduced and sustained in the diet for 3 months in each study arm.
Time frame
Baseline up to six months.2
Compare the allergenic food intake frequency.
Characterize diet diversity between the standard of care arm and the experimental arm.
Time frame
At the start of intervention and month 1, month 2, month 3, month 4, and month 6.Sponsors and contacts
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Source ClinicalTrials.gov