[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618573":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":64,"collaborators":24,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":24,"enrollmentInfo":77,"targetDuration":24,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":94,"whyStopped":24,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Pontificia Universidad Catolica de Chile","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Retain vernix caseosa","EXPERIMENTAL","After delivery, visible blood and fluids are gently wiped from the newborn's skin while leaving the vernix caseosa intact. Bathing or cleansing with water or oil is delayed for at least 24 hours (preferably up to 7 days) according to the study protocol. Excess vernix may be lightly spread across the body surface to ensure even coverage. Standard thermal care, skin-to-skin contact, and other routine newborn procedures are maintained. No emollients or cleansers are applied during the retention period.",[13],"Other: Retention of Vernix Caseosa After Birth",{"label":15,"type":6,"description":16,"interventionNames":17},"Early removal of vernix caseosa","Within two hours after birth, newborns receive standard hospital cleansing with sterile water and vegetable oil or petroleum jelly to completely remove vernix caseosa, blood, and other residues. The procedure follows routine postnatal care practices at each participating site. After cleaning, usual thermal care, dressing, and parental skin-to-skin contact are continued. No experimental procedures or restrictions are applied beyond standard care.",[18],"Other: Removal of Vernix Caseosa After Birth",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Retention of Vernix Caseosa After Birth","Retention of vernix caseosa on the newborn's skin after birth by avoiding early cleaning or bathing for ≥24 hours, allowing it to dry and absorb naturally.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Removal of Vernix Caseosa After Birth","Early removal of vernix caseosa from the newborn's skin within the first two hours after birth by washing the child with water and petroleum jelly or vegetable oil, as is standard practice in study hospitals.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Arturo Borzutzky, M.D","CONTACT","+56223543753","aborzutz@uc.cl",[36,51],{"facility":37,"status":24,"city":38,"state":39,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Clínica San Carlos de Apoquindo","Las Condes","RM","Chile","CL",{"type":43,"coordinates":44},"Point",[45,46],-70.56413,-33.41636,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":33,"phoneExt":24,"email":34},"Arturo Borzutzky, M.D.",{"facility":52,"status":24,"city":53,"state":39,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Hospital Clínico Universidad Católica","Santiago",{"type":43,"coordinates":55},[56,57],-70.64827,-33.45694,{"lat":57,"lon":56},[60,61],{"name":50,"role":32,"phone":33,"phoneExt":24,"email":34},{"name":62,"role":32,"phone":24,"phoneExt":24,"email":63},"Paula Fajuri, R.N.","protego@uc.cl",{"type":65,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100618573","retention-of-vernix-caseosa-in-newborns-for-primary-prevention-of-atopic-dermatitis-100618573",false,"NCT07333378","Retention of Vernix Caseosa in Newborns for Primary Prevention of Atopic Dermatitis","Post-partum Retention of Vernix Caseosa for Primary Prevention of Atopic Dermatitis, Guarding Skin Integrity and Fostering a Healthy Microbiome.","PROTEGO","Inclusion Criteria:\n\n* pregnant mother aged 18 and older, who is able to provide informed consent for participation\n* delivery of a healthy, singleton newborn (vaginal or cesarean) at one of the study sites.\n* parents are able and willing to comply with the study schedule and procedures\n\nExclusion Criteria:\n\n* birthweight \\\u003C2000 g\n* prematurity younger than 34 weeks of gestation\n* multiple gestation \u002F multiple births\n* maternal HIV-positivity\n* clinical and\u002For laboratory diagnosis of chorioamnionitis.\n* need for neonatal hospitalization or presence of an acute illness (e.g., neonatal respiratory distress syndrome) within the first 24 hours of life.\n* severe and generalized congenital skin disorder (e.g., congenital ichthyosis).",true,"ALL","0 Days",{"count":78,"type":79},1383,"ESTIMATED","INTERVENTIONAL",[82],"NA","Atopic dermatitis (AD), also known as eczema, is a common chronic inflammatory skin disease that usually begins in infancy and causes significant itching, discomfort, and sleep disturbance. It affects up to one in five children worldwide and represents a growing public-health problem. Research has shown that genetic and environmental factors contribute to its development, especially those related to skin-barrier integrity and the skin microbiome during early life. Preventing AD before it starts-known as primary prevention-has become an important goal.\n\nVernix caseosa is a naturally occurring, white, creamy substance that covers the skin of newborns at birth. It forms during the last trimester of pregnancy and plays a key role in protecting and hydrating the baby's skin before and after birth. Vernix contains water, lipids, and proteins with antimicrobial and anti-inflammatory properties. Despite these potential benefits, in many hospitals vernix is routinely removed soon after delivery as part of standard newborn cleaning or bathing practices. However, there is little scientific evidence to support early removal, and some studies suggest that keeping vernix on the skin for longer may help the newborn's skin barrier function and reduce colonization by harmful bacteria.\n\nThe PROTEGO Study (Post-Partum Retention of Vernix Caseosa for Primary Prevention of Atopic Dermatitis, Guarding Skin Integrity and Fostering a Healthy Microbiome) is a randomized controlled clinical trial designed to test whether delaying the removal of vernix caseosa after birth can help prevent atopic dermatitis and improve skin health during the first year of life.\n\nA total of 1,383 mother-infant pairs will be enrolled from three maternity hospitals in Santiago, Chile. Participants will be randomly assigned to one of two groups:\n\n1. Retention group: Vernix caseosa will be left on the skin and allowed to dry naturally; the baby's first bath will be delayed according to the study protocol.\n2. Removal group: Vernix will be removed following current hospital practice using gentle cleaning with water and oil or petroleum jelly shortly after birth.\n\nAll infants will be followed for 12 months with regular clinical assessments, standardized skin evaluations, and collection of biological samples. The main outcome will be the cumulative incidence of atopic dermatitis, diagnosed using modified UK Working Party criteria and\u002For Hanifin \\& Rajka criteria at 12 months of age. Secondary outcomes include skin-barrier measurements (transepidermal water loss, skin pH, and natural moisturizing factor), the composition of the skin microbiome, and early signs of allergic or infectious diseases.\n\nThis study will provide high-quality evidence on whether preserving vernix caseosa after birth is a simple, safe, cost-effective and natural strategy to strengthen the newborn's skin barrier and reduce the risk of eczema and related conditions. The results could help improve newborn-care practices and promote skin health in early life worldwide.",[85],"Atopic Dermatitis",[87,88,89,90,91,92,93],"vernix caseosa","primary prevention","newborn","eczema","atopic dermatitis","skin infections","Staphylococcus aureus","NOT_YET_RECRUITING","2025-12-30",{"date":97,"type":98},"2026-01-12","ACTUAL",{"date":100,"type":79},"2026-01-02",{"date":102,"type":79},"2028-03-31",{"name":5,"class":6},2]