Multi-component Environmental Package for Food Allergy Prevention

(SHAPE Trial)

Overseen By Mackenzie Haggstrom, BHSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Vertically transmitted diseases, Severe maternal conditions, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Derek Chu, MD, PhD, FRCPC

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

Inclusion Criteria

My baby was born healthy and at or after 37 weeks of pregnancy.

Newborn with any of the following risk factors: only child, first-degree relatives with history of food allergy, allergic rhinitis/conjunctivitis, asthma, or atopic dermatitis

Parent(s)/guardian provided informed consent for the child's study participation

Exclusion Criteria

No access to phone, internet, or email

Newborns born to mothers with positive routine prenatal screening for vertically transmitted diseases

Inability to adhere to study procedures due to severe maternal conditions or neonatal skin conditions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 8 weeks

1 visit (in-person)

Randomization and Initial Instructions

Participants are randomized to either the multi-component environmental package or regular care and receive initial instructions

Within 24 hours of birth

1 visit (in-person)

Treatment

Participants follow the assigned care regimen, with adherence tracked through weekly diaries and web-based questionnaires

12 months

In-office visits at 4 and 12 months, web-based questionnaires at 4, 6, 9, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of food allergy and atopic dermatitis

Up to 18 months

Follow-up assessments as needed

What Are the Treatments Tested in This Trial?

Interventions

• Multi-component environmental package

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

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.

Group II: Control Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+