SHAPE-pilottitutkimus: ihon terveys ja allergioiden ehkäisy altistumisella (SHAPE)

Description of the recommendations included in the intervention package

1. Delay first bath until target of 7 days after birth and use only water for the first bath (i.e. no soap or cleanser).
2. Bathe a target of once per week.
3. Avoid bubble baths, harsh soaps and detergents (e.g. surfactants- or lye-containing agents detailed below).
4. Avoid using antimicrobial (disinfectant) wipes (e.g. "wet wipes" such as Dr. Brown's, Parent's choice, Aleva Naturals, Munchkin Arm & Hammer, Chicco cleaning wipes) for cleaning skin outside of the perineum/anus.
5. Avoid using dishwasher with detergents or rinse-aids for washing baby feeding devices, soothers, and toys (e.g. breast pump, nursing bottles, nipples, pacifiers, teething devices, or toys).
6. Avoid exposing the skin to food, e.g. eating over top of baby, or handling baby with food residue on hands (e.g. peanut butter), or kissing baby with food residue on lips or in mouth.

Participants randomized to the intervention group (MEP) will be advised to follow the following 6 recommendations:

1. Delay first bath until target of 7 days after birth and use only water for the first bath (i.e. no soap or cleanser).
2. Bathe a target of once per week.
3. Avoid bubble baths, harsh soaps and detergents (e.g. surfactants- or lye-containing agents detailed below).
4. Avoid using antimicrobial (disinfectant) wipes (e.g. "wet wipes" such as Dr. Brown's, Parent's choice, Aleva Naturals, Munchkin Arm & Hammer, Chicco cleaning wipes) for cleaning skin outside of the perineum/anus.
5. Avoid using dishwasher with detergents or rinse-aids for washing baby feeding devices, soothers, and toys (e.g. breast pump, nursing bottles, nipples, pacifiers, teething devices, or toys).
6. Avoid exposing the skin to food, e.g. eating over top of baby, or handling baby with food residue on hands (e.g. peanut butter), or kissing baby with food residue on lips or in mouth.

If assigned to the control group, the parents will be advised to continue their preferred routine practices.

If assigned to the control group, the parents will be advised to continue their preferred routine practices.

Investigators will measure the proportion of participants adhering to the protocol (MEP or control). Parents will log weekly details about bathing frequency, use of soap or detergents for bathing or using detergents for cleaning baby essentials and environmental exposure of food allergen to skin in weekly electronic diary card using REDCap. Reasons for non-adherence will be recorded for both groups. Successful adherence is anticipated if at least 50% of the participants completes the adherence form at the four study (4, 6, 9 and 12 months of age) time points and completes weekly diary card (at least 38 out of 52 weeks of follow-up).

Investigators will determine the number of participants randomized to study groups (Group 1 or 2) over one year from the date of first accrual. A screening log will track eligible newborns and be used to assess the recruitment rate every week.

Study staff will track the proportion of participants completing all scheduled follow-ups and providing complete data. Reasons for incomplete data will be recorded for both groups (e.g., admission to hospital due to any illness) from process-related reasons (i.e., insufficient reminders, too difficult to implement, other reasons specified by parents).

Parents will record symptoms related to food allergy reactions, skin and gastrointestinal conditions such as redness, itching, blistering, or crusting of skin, diarrhea, and vomiting on weekly diary and survey questionnaire during the scheduled follow-up. the study period until 12 months of age. Study staff will track the number and severity of these symptoms through parental reporting, clinical exam, and routine medical records until 12 months of age.

The proportion of diagnosed food allergy confirmed by clinical evaluation, by 12 (up to 18) months of age. The study will have a wide window of up to 18 months of age to accommodate multiple oral food challenge (OFCs) for individual infants as per routine clinical care.

Diagnosed cases of AD based on UK Working Party Diagnostic Criteria (UKWP) anytime confirmed at two separate time points, at least 1 month apart, between birth and 12 months of age. Blinded clinicians will assess AD. Parents of the infant will report severity of AD using Patient-Oriented Eczema Measure (POEM) while parents, clinicians and study staff will report severity using Scoring atopic dermatitis (SCORAD).