[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618573":3},{"organization":4,"outcomesModule":7,"designInfo":101,"detailedDescription":112,"studyPopulation":106,"armGroups":113,"interventions":125,"overallOfficials":106,"centralContacts":134,"locations":140,"responsibleParty":169,"collaborators":106,"id":171,"slug":106,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":178,"sex":179,"minAge":180,"maxAge":106,"enrollmentInfo":181,"targetDuration":106,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":198,"whyStopped":106,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},{"fullName":5,"class":6},"Pontificia Universidad Catolica de Chile","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":77},[9],{"measure":10,"description":11,"timeFrame":12},"Cumulative incidence of atopic dermatitis at 1 year of age","Proportion of infants who meet the diagnostic criteria for atopic dermatitis at 12 months of age, assessed using the modified UK Working Party criteria and\u002For Hanifin \\& Rajka criteria, evaluated by a trained assessor blinded to group allocation.","12 months",[14,18,22,25,28,31,34,37,41,44,48,51,54,57,60,64,67,71,74],{"measure":15,"description":16,"timeFrame":17},"Incidence of Atopic Dermatitis (Hanifin & Rajka Criteria Only)","Proportion of infants diagnosed with atopic dermatitis at 12 months using only the Hanifin \\& Rajka criteria.","12 months.",{"measure":19,"description":20,"timeFrame":21},"Cumulative Incidence of Atopic Dermatitis (Modified UK Working Party Criteria Only)","Proportion of infants diagnosed with atopic dermatitis using only the modified UK Working Party criteria for atopic dermatitis at any study contact until 12 months.","0-12 months",{"measure":23,"description":24,"timeFrame":21},"Cumulative Incidence of Infant Eczema","Proportion of infants with any eczema skin lesions (clinician or parent-reported) up to 12 months of age.",{"measure":26,"description":27,"timeFrame":12},"Atopic dermatitis diagnosed by trained physician","Diagnosis of atopic dermatitis by a trained physician using standard clinical criteria at 12 months of age",{"measure":29,"description":30,"timeFrame":21},"Parent-reported atopic dermatitis","Parental report of a physician diagnosis of atopic dermatitis collected via standardized questionnaire.",{"measure":32,"description":33,"timeFrame":21},"Cumulative incidence of atopic dermatitis by CEQ at 12 months","Cumulative incidence of AD diagnosed using the Children's Eczema Questionnaire (CEQ).",{"measure":35,"description":36,"timeFrame":21},"Use of topical anti-inflammatory medications","Any reported use of atopic dermatitis topical medications, such as corticosteroids or calcineurin inhibitors, during the first 12 months of age.",{"measure":38,"description":39,"timeFrame":40},"Time to onset of AD based on parent-reported age at first appearance among infants with AD","Time to onset of AD based on parent-reported age at first appearance among infants with AD.","From birth to 12 months of age",{"measure":42,"description":43,"timeFrame":40},"AD severity measured by the Patient-Oriented Eczema Measure (POEM) among infants with AD","AD severity measured by the Patient-Oriented Eczema Measure (POEM) among infants with AD.",{"measure":45,"description":46,"timeFrame":47},"Severity of Atopic Dermatitis (SCORAD) among infants with AD","Severity of Atopic Dermatitis (SCORAD) among infants with AD at 12 months of age.","12 months of age",{"measure":49,"description":50,"timeFrame":40},"Global AD severity based on parental assessment among infants with AD","Global AD severity based on parental assessment among infants with AD.",{"measure":52,"description":53,"timeFrame":21},"Interaction of intervention with visible vernix caseosa (VC) at birth","Evaluate the effects of the amount of visible VC on the incidence of AD in the intervention and control groups.",{"measure":55,"description":56,"timeFrame":21},"Interaction of intervention with FLG loss-of-function mutations","Evaluate the effects of FLG loss-of-function mutations on the incidence of AD in the intervention and control groups.",{"measure":58,"description":59,"timeFrame":21},"Dynamics of Staphylococcal Colonization","Cumulative incidence of positive Staphylococcus aureus (and other Staphylococcal species) identification on the skin during the first year of life.",{"measure":61,"description":62,"timeFrame":63},"Transepidermal water loss (TEWL) at 24-96 hours of age","Measurement of transepidermal water loss (TEWL) at 24-96 hours of age","24-96 hours",{"measure":65,"description":66,"timeFrame":47},"Transepidermal water loss (TEWL) at 12 months of age","Measurement of transepidermal water loss (TEWL) at 12 months of age.",{"measure":68,"description":69,"timeFrame":70},"Skin pH at 24-96 hours of age","Measurement of skin pH at 24-96 hours of age.","24-96 hours of age",{"measure":72,"description":73,"timeFrame":47},"Skin pH at 12 months of age","Measurement of skin pH at 12 months of age.",{"measure":75,"description":76,"timeFrame":47},"Epidermal natural moisturizing factor (NMF) concentration at 12 months.","Epidermal natural moisturizing factor (NMF) concentration in tape stripping samples at 12 months of age.",[78,82,86,89,92,95,98],{"measure":79,"description":80,"timeFrame":81},"Newborn temperature regulation","Serial measurements of body temperature during the first 24 hours of life.","0-24 hours of life",{"measure":83,"description":84,"timeFrame":85},"Serious bacterial infections","Incidence of serious bacterial infections at 28 and 90 days.","28 and 90 days of life",{"measure":87,"description":88,"timeFrame":21},"Skin infections during infancy","Cumulative incidence of bacterial skin infections during the first 12 months of life.",{"measure":90,"description":91,"timeFrame":12},"Parent-reported food allergy incidence","Cumulative incidence of food allergy based on Parent-reported immediate symptoms of food allergy.",{"measure":93,"description":94,"timeFrame":12},"Physician-diagnosed food allergy incidence","Cumulative incidence of food allergy based on parent-reported physician-diagnosed food allergy confirmed by skin-prick test, specific IgE, or oral food challenge.",{"measure":96,"description":97,"timeFrame":12},"Parental Acceptability of Vernix Retention vs. Removal","Acceptability and satisfaction with assigned intervention assessed via parental questionnaire.",{"measure":99,"description":100,"timeFrame":47},"Type-2 immunity biomarkers in stratum corneum transcriptomics","Comparison of gene-expression markers of type-2 immunity in the stratum corneum at 12 months between VC retention and early removal groups.",{"allocation":102,"interventionModel":103,"interventionModelDescription":104,"primaryPurpose":105,"observationalModel":106,"timePerspective":106,"maskingInfo":107},"RANDOMIZED","PARALLEL","Multicenter, randomized, controlled, parallel-group trial conducted in three maternity hospitals in Santiago, Chile. Mother-infant pairs are assigned 1:1 to either vernix retention (experimental) or vernix removal (control). In the retention arm, vernix caseosa is left on the skin and bathing is delayed ≥24 h; in the control arm, vernix is removed within 2 hours per standard care. Randomization is centralized via an Interactive Response Technology (IRT) system and stratified by site, delivery mode, and parental atopy. The study uses a single-blind (assessor-blinded) design with 12-month follow-up. Primary purpose: prevention of atopic dermatitis through improved skin-barrier and microbiome development.","PREVENTION",null,{"masking":108,"maskingDescription":109,"whoMasked":110},"SINGLE","Due to the nature of the intervention, masking of mothers, families, and delivery staff is not feasible. The trial uses a single-blind design, where outcome assessors, investigators performing clinical evaluations, data analysts, and laboratory personnel are blinded to treatment allocation. Randomization and group assignment are managed centrally through a secure Interactive Response Technology (IRT) system to ensure allocation concealment. Study documentation and sample labels use coded identifiers to maintain blinding throughout data collection and analysis.",[111],"OUTCOMES_ASSESSOR","Scientific Rationale:\n\nAtopic dermatitis (AD) is a chronic, relapsing, inflammatory skin disorder that typically begins in early childhood and is characterized by pruritic eczematous lesions, epidermal barrier dysfunction, and immune dysregulation. Its prevalence is rising globally, affecting 10-35 % of children in industrialized countries. In Chile, epidemiological studies show that 18-22 % of school-aged children and up to one third of toddlers have physician-diagnosed AD, indicating a substantial and increasing disease burden. AD is often the first manifestation of the \"atopic march,\" leading to food allergy, asthma, and allergic rhinitis.\n\nAlthough several biologic and small-molecule therapies have recently transformed the management of moderate-to-severe AD, these treatments remain costly, inaccessible for most patients, and do not prevent disease onset. Therefore, identifying effective and feasible primary prevention strategies is a major unmet need.\n\nCurrent understanding of AD pathogenesis highlights three interacting domains: (1) structural and biochemical defects of the epidermal barrier; (2) skewed type-2 immune responses; and (3) altered skin microbiota with increased colonization by Staphylococcus aureus. Defects in epidermal proteins such as filaggrin (FLG) increase transepidermal water loss (TEWL) and permeability to allergens and microbes, while immune activation and microbial imbalance perpetuate inflammation. Because these abnormalities emerge early in life-often before clinical symptoms-interventions targeting skin-barrier maturation and microbial balance during the neonatal period may reduce AD incidence.\n\nVernix Caseosa as a Natural Barrier Protector:\n\nVernix caseosa (VC) is a unique biofilm-like substance produced in utero by fetal sebaceous glands and composed of water (≈ 80 %), lipids (≈ 10 %), and proteins (≈ 10 %) intermingled with corneocytes. It covers the fetus during the third trimester, protecting the skin from maceration in the amniotic environment and promoting terminal differentiation of the stratum corneum. VC exhibits semipermeable and antimicrobial properties, functioning as a physiological barrier and innate immune interface. Its lipids include ceramides, cholesterol, and free fatty acids-key constituents of postnatal epidermal barrier repair-while its proteins include antimicrobial peptides such as LL-37, psoriasin, RNase 7, and lysozyme, as well as enzymes involved in lipid metabolism.\n\nDespite these potential benefits, in many institutions worldwide VC is routinely removed within hours after birth as part of standard newborn cleaning procedures. Early removal eliminates a biologically active matrix that may support optimal skin barrier transition from intrauterine to extrauterine life. Small randomized and observational studies suggest that delaying vernix removal increases skin hydration, lowers skin pH, and may reduce bacterial colonization by S. aureus and E. coli, but evidence is limited by short follow-up and small sample sizes and no studies have evaluated its long-term impact on incidence of atopic dermatitis and other conditions.\n\nThe PROTEGO trial aims to test whether retaining vernix caseosa after birth, compared with its routine early removal, reduces the risk of developing AD during the first year of life and improves biophysical and microbiological indicators of skin health.\n\nStudy Design:\n\nPROTEGO is a multicenter, randomized, controlled, parallel-group clinical trial with assessor blinding. The trial will enroll 1,383 pregnant women and their newborns from three high-volume maternity hospitals in Santiago, Chile. Eligible participants are healthy mothers ≥ 18 years of age with singleton pregnancies and expected delivery of a healthy neonate (≥ 34 weeks, birthweight ≥ 2000 g). After written informed consent, participants will be randomly assigned 1:1 via a centralized interactive response technology (IRT) system to either the vernix retention group or the vernix removal group. Randomization is stratified by clinical site, mode of delivery (vaginal\u002Fcesarean), and parental history of atopy.\n\nBecause masking of the delivery team and parents is not feasible, the study will use single-blind assessment, ensuring that investigators evaluating outcomes remain unaware of group assignment. Participants will be followed from birth to 12 months through scheduled visits (at 24-96 h; 7 days; and 1, 3, 6, 9, and 12 months).\n\nSafety and Monitoring:\n\nRetention or removal of VC are standard practices varying between institutions and are considered a minimal-risk intervention. Potential risks include mild skin irritation, transient erythema, or theoretical risk of hypothermia if bathing is delayed excessively. These will be mitigated by standard neonatal thermal-care protocols and skin monitoring. Adverse events (AEs) and serious adverse events (SAEs) will be actively monitored and reported according to institutional and national regulations.\n\nExpected Impact:\n\nIf vernix retention proves effective, this trial could introduce a simple, low-cost, and universally applicable strategy for the primary prevention of atopic dermatitis. Because the intervention involves modifying routine newborn care rather than introducing new drugs or devices, it has high translational potential for maternity wards worldwide, especially in low- and middle-income settings.\n\nBeyond its clinical endpoint, PROTEGO will generate valuable mechanistic insights into early-life skin-barrier biology, the neonatal microbiome, and gene-environment interactions (e.g., FLG variants). The integrated biophysical, microbiological, and transcriptomic datasets may illuminate new pathways linking perinatal skin care and immune development. PROTEGO is the first large-scale randomized controlled trial evaluating whether the simple act of preserving vernix caseosa after birth can prevent atopic dermatitis. By combining clinical follow-up with state-of-the-art barrier and microbiome analyses, this study seeks to redefine evidence-based newborn-skin care and contribute to global efforts to reduce the burden of allergic and inflammatory diseases from the very beginning of life.",[114,120],{"label":115,"type":116,"description":117,"interventionNames":118},"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.",[119],"Other: Retention of Vernix Caseosa After Birth",{"label":121,"type":6,"description":122,"interventionNames":123},"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.",[124],"Other: Removal of Vernix Caseosa After Birth",[126,130],{"type":6,"name":127,"description":128,"armGroupLabels":129,"otherNames":106},"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.",[115],{"type":6,"name":131,"description":132,"armGroupLabels":133,"otherNames":106},"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.",[121],[135],{"name":136,"role":137,"phone":138,"phoneExt":106,"email":139},"Arturo Borzutzky, M.D","CONTACT","+56223543753","aborzutz@uc.cl",[141,156],{"facility":142,"status":106,"city":143,"state":144,"zip":106,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":152,"contacts":153},"Clínica San Carlos de Apoquindo","Las Condes","RM","Chile","CL",{"type":148,"coordinates":149},"Point",[150,151],-70.56413,-33.41636,{"lat":151,"lon":150},[154],{"name":155,"role":137,"phone":138,"phoneExt":106,"email":139},"Arturo Borzutzky, M.D.",{"facility":157,"status":106,"city":158,"state":144,"zip":106,"country":145,"countryCode":146,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Hospital Clínico Universidad Católica","Santiago",{"type":148,"coordinates":160},[161,162],-70.64827,-33.45694,{"lat":162,"lon":161},[165,166],{"name":155,"role":137,"phone":138,"phoneExt":106,"email":139},{"name":167,"role":137,"phone":106,"phoneExt":106,"email":168},"Paula Fajuri, R.N.","protego@uc.cl",{"type":170,"investigatorFullName":106,"investigatorTitle":106,"investigatorAffiliation":106,"oldNameTitle":106,"oldOrganization":106},"SPONSOR","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":182,"type":183},1383,"ESTIMATED","INTERVENTIONAL",[186],"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.",[189],"Atopic Dermatitis",[191,192,193,194,195,196,197],"vernix caseosa","primary prevention","newborn","eczema","atopic dermatitis","skin infections","Staphylococcus aureus","NOT_YET_RECRUITING","2025-12-30",{"date":201,"type":202},"2026-01-12","ACTUAL",{"date":204,"type":183},"2026-01-02",{"date":206,"type":183},"2028-03-31",{"name":5,"class":6},2]