[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630543":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":43,"responsibleParty":64,"collaborators":24,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":24,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":91,"whyStopped":24,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"McMaster University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","Description of the recommendations included in the intervention package\n\n1. Delay first bath until target of 7 days after birth and use only water for the first bath (i.e. no soap or cleanser).\n2. Bathe a target of once per week.\n3. Avoid bubble baths, harsh soaps and detergents (e.g. surfactants- or lye-containing agents detailed below).\n4. 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\u002Fanus.\n5. 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).\n6. 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.",[13],"Other: Multi-component environmental package",{"label":15,"type":6,"description":16,"interventionNames":17},"Control Group","If assigned to the control group, the parents will be advised to continue their preferred routine practices.",[18],"Other: standard of care",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Multi-component environmental package","Participants randomized to the intervention group (MEP) will be advised to follow the following 6 recommendations:\n\n1. Delay first bath until target of 7 days after birth and use only water for the first bath (i.e. no soap or cleanser).\n2. Bathe a target of once per week.\n3. Avoid bubble baths, harsh soaps and detergents (e.g. surfactants- or lye-containing agents detailed below).\n4. 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\u002Fanus.\n5. 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).\n6. 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.",[9],null,{"type":6,"name":26,"description":16,"armGroupLabels":27,"otherNames":24},"standard of care",[15],[29],{"name":30,"affiliation":5,"role":31},"Derek Chu, MD, PhD, FRCPC","PRINCIPAL_INVESTIGATOR",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Tasnuva Ahmed, MPH","CONTACT","905-525-9140","21349","ahmedt57@mcmaster.ca",{"name":40,"role":35,"phone":36,"phoneExt":41,"email":42},"Mackenzie Haggstrom, BHSc","21334","haggstrm@mcmaster.ca",[44],{"facility":45,"status":24,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"McMaster University Medical Centre","Hamilton","Ontario","L8N 3Z5","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-79.84963,43.25011,{"lat":55,"lon":54},[58,59,60,61],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},{"name":40,"role":35,"phone":36,"phoneExt":41,"email":42},{"name":30,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":62,"role":63,"phone":24,"phoneExt":24,"email":24},"Rohan D'Souza, MD, PhD, FRCOG","SUB_INVESTIGATOR",{"type":65,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100630543","shape-trial-skin-health-and-allergy-prevention-exposure-100630543",false,"NCT07489040","SHAPE Trial: Skin Health and Allergy Prevention Exposure","Multi-component Package for Skin Health and Allergen Exposure Strategy to Prevent Food Allergy","SHAPE","Inclusion Criteria:\n\n1. 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).\n2. 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\u002For siblings) with history of food allergy, allergic rhinitis\u002Fconjunctivitis, asthma, or atopic dermatitis.\n3. Parent(s)\u002Fguardian provided informed consent for the child's study participation.\n\nExclusion Criteria:\n\n1. 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.\n2. 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.\n3. 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.\n4. No access to phone, internet, or email (requirements to contact participant\u002Fguardian).\n5. Planning to move out of the province within 12 months of study enrollment.","ALL","37 Weeks","42 Weeks",{"count":78,"type":79},64,"ESTIMATED","INTERVENTIONAL",[82],"NA","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.\n\nResearchers will compare the multi-component environmental package to regular care to see if the MEP works to prevent food allergies. Participants will:\n\n* Be assigned to the multi-component environmental package or regular care once their baby is born\n* Complete a weekly diary\n* Attend in-office visits at 4 and 12 months of age\n* Complete web-based questionnaires at 4, 6, 9 and 12 months of age",[85],"Allergy and Immunology",[87,88,89,90],"Allergy","Allergy prevention","Skin health","Food allergy","NOT_YET_RECRUITING","2026-03-31",{"date":94,"type":95},"2026-04-06","ACTUAL",{"date":97,"type":79},"2026-04-01",{"date":99,"type":79},"2028-12-31",{"name":5,"class":6},1]