SHAPE Trial: Skin Health and Allergy Prevention Exposure

ConditionAllergy and Immunology

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age37-42

SponsorMcMaster University

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

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.

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

Disqualifiers

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.

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.

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.

No access to phone, internet, or email (requirements to contact participant/guardian).

Trial design

Design model

Parallel

Treatments tested in this trial

Multi-component environmental package
Other intervention
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
Other intervention
If assigned to the control group, the parents will be advised to continue their preferred routine practices.

Treatment groups

64 Participants

are divided into 2 treatment groups

Group A: Intervention GroupExperimental treatment 1 intervention

Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

Web-based questionnaires at 4, 6, 9 and 12 months will track adherence.

Recruitment

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.

Time frame

12- months from study initiation

Retention

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).

Time frame

Web-based questionnaire at 4, 6, 9, and 12 month age follow-up

Secondary outcomes

Data collection on number of adverse events (AE) related to allergic reactions, skin and gastrointestinal conditions

Parents will record symptoms related to food allergy reactions, skin and gastrointestinal conditions such as redness, itching, blistering, or crusting of skin, diarrhea, and vomiting on weekly diary and survey questionnaire during the scheduled follow-up. the study period until 12 months of age. Study staff will track the number and severity of these symptoms through parental reporting, clinical exam, and routine medical records until 12 months of age.

Time frame

Until 12 months of age (end of study)

Other outcomes

Diagnosed Food allergy

The proportion of diagnosed food allergy confirmed by clinical evaluation, by 12 (up to 18) months of age. The study will have a wide window of up to 18 months of age to accommodate multiple oral food challenge (OFCs) for individual infants as per routine clinical care.

Time frame

12 (up to 18) months of age (end of study)

Diagnosed Atopic dermatitis (AD)

Diagnosed cases of AD based on UK Working Party Diagnostic Criteria (UKWP) anytime confirmed at two separate time points, at least 1 month apart, between birth and 12 months of age. Blinded clinicians will assess AD. Parents of the infant will report severity of AD using Patient-Oriented Eczema Measure (POEM) while parents, clinicians and study staff will report severity using Scoring atopic dermatitis (SCORAD).

Time frame

4-, 6-, 9-, and 12-months age follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

Source ClinicalTrials.gov

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