Recruiting

Multi-Component Environmental Package

Sponsor:

McMaster University

Code:

NCT07489040

Conditions

Allergy and Immunology

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Multi-component environmental package

standard of care

Study Details

Brief 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

Conditions

Allergy and Immunology

Study ID

NCT07489040

Start date

Jun 15, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Group

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.

other: Control Group

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

Interventions

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.

Primary outcome measure

  • Adherence [ Time Frame: Web-based questionnaires at 4, 6, 9 and 12 months will track adherence. ]
  • Recruitment [ Time Frame: 12- months from study initiation ]
  • Retention [ Time Frame: Web-based questionnaire at 4, 6, 9, and 12 month age follow-up ]

Central Contacts and Locations

Central contacts

Locations

McMaster University Medical Centre

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Principal Investigator:

Derek Chu, MD, PhD, FRCPC

More Information

Sponsor

McMaster University

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Keywords

  • Allergy
  • Allergy prevention
  • Skin health
  • Food allergy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by McMaster University on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.