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NOT YET RECRUITING
NCT07489040
NA

SHAPE Trial: Skin Health and Allergy Prevention Exposure

Sponsor: McMaster University

View on ClinicalTrials.gov

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

Official title: Multi-component Package for Skin Health and Allergen Exposure Strategy to Prevent Food Allergy

Key Details

Gender

All

Age Range

37 Weeks - 42 Weeks

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2026-04-01

Completion Date

2028-12-31

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

OTHER

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.

OTHER

standard of care

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

Locations (1)

McMaster University Medical Centre

Hamilton, Ontario, Canada