Preventing food allergy in infants with early introduction of complementary feeding: feasibility and cluster randomised controlled trial
Preventing food allergy in infants
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 Newcastle, which covers a large, ethnically mixed inner-city population, and Southampton, which covers a large, less ethnically diverse inner-city and rural population. The proposed control sites are South Tees, which is a smaller, ethnically diverse city population, and the Isle of Wight, which is a small, ethnically less diverse, semi-rural population. All four areas are socioeconomically diverse. Allocating the two large sites to intervention in the feasibility study will allow a different group of general practices to be used for recruitment in the effectiveness trial to prevent contamination if the site is randomized to control. The intervention site feasibility objectives (recruitment rate, acceptability, safety, age of introduction and frequency of consumption, proportion assessed at 30-weeks of age) mean that participants will need to be followed to 30-months of age. Participants will also be assessed at 52-weeks of age to provide them with the benefit of a food allergy assessment, but the data will not be used as part of the assessment of trial feasibility. The control site feasibility objectives (recruitment rate, safety, age of introduction and frequency of consumption, proportion assessed at 30- and 52-weeks of age) mean that participants will be followed to 52-weeks of age. This design has been chosen for efficiency as it allows the control groups to be recruited before the intervention is finalized. The feasibility study outcome will be collected in the same time period, minimizing the length of the program. Effectiveness Trial (WP3) A phase 3 cluster randomized controlled trial design. Again, the trial will use a cluster design with each site being a different hospital (although some Trusts may cover more than one hospital). This approach is taken
1. Infants aged 0-3 months and their parents/carers 2. Willing and able to give written informed consent
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.