Post-partum Retention of Vernix Caseosa for Primary Prevention of Atopic Dermatitis, Guarding Skin Integrity and Fostering a Healthy Microbiome.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,383
- 试验地点
- 2
- 主要终点
- Cumulative incidence of atopic dermatitis at 1 year of age
研究概览
简要总结
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.
Vernix 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.
The 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.
A 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:
- 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.
- Removal group: Vernix will be removed following current hospital practice using gentle cleaning with water and oil or petroleum jelly shortly after birth.
All 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/or 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.
This 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.
详细描述
Scientific Rationale:
Atopic 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.
Although 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.
Current 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.
Vernix Caseosa as a Natural Barrier Protector:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 0 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •pregnant mother aged 18 and older, who is able to provide informed consent for participation
- •delivery of a healthy, singleton newborn (vaginal or cesarean) at one of the study sites.
- •parents are able and willing to comply with the study schedule and procedures
排除标准
- •birthweight <2000 g
- •prematurity younger than 34 weeks of gestation
- •multiple gestation / multiple births
- •maternal HIV-positivity
- •clinical and/or laboratory diagnosis of chorioamnionitis.
- •need for neonatal hospitalization or presence of an acute illness (e.g., neonatal respiratory distress syndrome) within the first 24 hours of life.
- •severe and generalized congenital skin disorder (e.g., congenital ichthyosis).
研究组 & 干预措施
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.
干预措施: Removal of Vernix Caseosa After Birth (Other)
Retain vernix caseosa
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.
干预措施: Retention of Vernix Caseosa After Birth (Other)
结局指标
主要结局
Cumulative incidence of atopic dermatitis at 1 year of age
时间窗: 12 months
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/or Hanifin \& Rajka criteria, evaluated by a trained assessor blinded to group allocation.
次要结局
- Incidence of Atopic Dermatitis (Hanifin & Rajka Criteria Only)(12 months.)
- Cumulative Incidence of Atopic Dermatitis (Modified UK Working Party Criteria Only)(0-12 months)
- Cumulative Incidence of Infant Eczema(0-12 months)
- Atopic dermatitis diagnosed by trained physician(12 months)
- Parent-reported atopic dermatitis(0-12 months)
- Cumulative incidence of atopic dermatitis by CEQ at 12 months(0-12 months)
- Use of topical anti-inflammatory medications(0-12 months)
- Time to onset of AD based on parent-reported age at first appearance among infants with AD(From birth to 12 months of age)
- AD severity measured by the Patient-Oriented Eczema Measure (POEM) among infants with AD(From birth to 12 months of age)
- Severity of Atopic Dermatitis (SCORAD) among infants with AD(12 months of age)
- Global AD severity based on parental assessment among infants with AD(From birth to 12 months of age)
- Interaction of intervention with visible vernix caseosa (VC) at birth(0-12 months)
- Interaction of intervention with FLG loss-of-function mutations(0-12 months)
- Dynamics of Staphylococcal Colonization(0-12 months)
- Transepidermal water loss (TEWL) at 24-96 hours of age(24-96 hours)
- Transepidermal water loss (TEWL) at 12 months of age(12 months of age)
- Skin pH at 24-96 hours of age(24-96 hours of age)
- Skin pH at 12 months of age(12 months of age)
- Epidermal natural moisturizing factor (NMF) concentration at 12 months.(12 months of age)