Multi-component environmental packagestandard of care
Multi-component environmental package: 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.
standard of care: If assigned to the control group, the parents will be advised to continue their preferred routine practices.
Study summary
The goal of this clinical trial is to determine if a multi-component environmental package (MEP) can prevent food allergies among infants at risk of developing food allergies in early life.
Researchers will compare the multi-component environmental package to regular care to see if the MEP works to prevent food allergies. Participants will:
* Be assigned to the multi-component environmental package or regular care once their baby is born
* Complete a weekly diary
* Attend in-office visits at 4 and 12 months of age
* Complete web-based questionnaires at 4, 6, 9 and 12 months of age
Eligibility
Sex
ALL
Min age
37 Weeks
Max age
42 Weeks
Healthy volunteers
No
Inclusion Criteria:
1. Healthy singleton, neonates born at term (gestational age ≥37 weeks) (e.g. newborn without complications such as severe respiratory conditions, major congenital abnormalities, severe inborn errors of immunity \[e.g. severe combined immunodeficiency\], severe neonatal infections, neurologic impairment, and major gastrointestinal disorders).
2. The newborn has any or at least one of the following risk factors: is an only child (no live siblings); first-degree relatives (parents and/or siblings) with history of food allergy, allergic rhinitis/conjunctivitis, asthma, or atopic dermatitis.
3. Parent(s)/guardian provided informed consent for the child's study participation.
Exclusion Criteria:
1. Newborns born to mothers with positive routine prenatal screening for any of the vertically transmitted diseases (e.g. hepatitis B, hepatitis C, active syphilis or genital herpes simplex, Chlamydia trachomatis, gonorrhea and human immunodeficiency virus \[HIV\]) that may prevent adherence to any of the recommendations of the environmental packages.
2. Inability to adhere to the study procedures, e.g. severe maternal conditions (e.g. eclampsia, life-threatening conditions requiring intensive care admission) or neonatal skin conditions that require specific care practices.
3. Ongoing participation in another interventional study (e.g. trials involving skin care with topical creams, medication or interventions related to allergy prevention) that may interfere with the current study.
4. No access to phone, internet, or email (requirements to contact participant/guardian).
5. Planning to move out of the province within 12 months of study enrollment.
Primary outcome measure(s)
Adherence — Web-based questionnaires at 4, 6, 9 and 12 months will track adherence. 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).
Recruitment — 12- months from study initiation 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.
Retention — Web-based questionnaire at 4, 6, 9, and 12 month age follow-up 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).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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