Shape: Skin health and allergy prevention in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot, single-center study randomizes newborns to receive a multi-component environmental package (MEP) or standard care. It uses a 1:1 allocation with assessor blinding to explore feasibility of implementing MEP aimed at promoting a healthy microbiome and reducing skin barrier disruption. Participants complete weekly diaries and web questionnaires and attend in-person visits at 4 and 12 months. The trial evaluates whether environmental practices—such as limited detergent use and controlled bathing—can reduce the development of food allergies in early life.

Why it matters

Who can join: the full rules

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.

Where it's running

• McMaster University Medical Centre
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Derek Chu, MD, PhD, FRCPC — McMaster University
• Study coordinator: Tasnuva Ahmed, MPH
• Email: ahmedt57@mcmaster.ca
• Phone: 905-525-9140

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.