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:
1. 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. 2. 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.
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
birthweight <2000 g
prematurity younger than 34 weeks of gestation
multiple gestation / multiple births
maternal HIV-positivity
Parallel
Retention of Vernix Caseosa After Birth
Other interventionRetention 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.
Removal of Vernix Caseosa After Birth
Other interventionEarly 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.
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/or Hanifin \& Rajka criteria, evaluated by a trained assessor blinded to group allocation.
Incidence of Atopic Dermatitis (Hanifin & Rajka Criteria Only)
Proportion of infants diagnosed with atopic dermatitis at 12 months using only the Hanifin \& Rajka criteria.
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.
Cumulative Incidence of Infant Eczema
Proportion of infants with any eczema skin lesions (clinician or parent-reported) up to 12 months of age.
Atopic dermatitis diagnosed by trained physician
Diagnosis of atopic dermatitis by a trained physician using standard clinical criteria at 12 months of age
Newborn temperature regulation
Serial measurements of body temperature during the first 24 hours of life.
Serious bacterial infections
Incidence of serious bacterial infections at 28 and 90 days.
Skin infections during infancy
Cumulative incidence of bacterial skin infections during the first 12 months of life.
Parent-reported food allergy incidence
Cumulative incidence of food allergy based on Parent-reported immediate symptoms of food allergy.
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