SHAPE Trial: Skin Health and Allergy Prevention Exposure
ConditionAllergy and Immunology
Trial statusNot yet recruiting
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
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
Treatments tested in this trial
- Multi-component environmental package
- standard of care
Treatment groups
64 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov