Preventing food allergy in infants Other
Conditions
Interventions
Feasibility: Cluster Controlled Feasibility Trial
We plan to recruit from four sites, allowing us to recruit a socioeconomically and ethnically diverse group. The proposed intervention group includes
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
0 Months to 3 Months
Inclusion criteria
Inclusion criteria: 1. Infants aged 0-3 months and their parents/carers 2. Willing and able to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Pre-existing food allergy to both peanut and hen's egg. 2. Previous child enrolled in the feasibility or effectiveness trial to prevent an infant experiencing environmental exposure to a food allergen when they are not eating; this does not exclude twins or other multiples being recruited into the study as one time point into the same cluster and therefore allocation. 3. Any major feeding issues unless feeding/gastroenterology clinic say are happy that infant is included. 4. Severe neurodisability that would make early complementary feeding inappropriate. 5. Significant developmental delay (e.g., extremely preterm infants, infants with genetic conditions such as trisomy 21) that would make early complementary feeding inappropriate. 6. Inherited metabolic disorders that necessitate specific feeding regimes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New onset IgE-mediated food allergy at 52-weeks of age to peanut and/or hen’s egg on the basis of IgE-mediated symptoms and evidence of specific IgE-sensitisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at 52 weeks' of age using patient records and questionnaire: 1. New onset IgE-mediated food allergy at 52-weeks of age to any food. 2. Age of introduction of peanut, hen’s egg, and cow’s milk, and consumption frequency (information will also be collected about other allergenic foods, including those frequently consumed by specific population groups such as lentils). 3. Resource use and quality of life. 4. Growth (reported weight and length at 12-months of age). 5. Breastfeeding. 6. Adverse events (AEs) elicited by: - Questionnaires (such as choking, anaphylaxis, allergic reactions). - Medical notes review (such as respiratory tract infections). | — |
Countries
England, United Kingdom
Contacts
Public ContactHelen Stacey
Outcome results
None listed