Retention of Vernix Caseosa in Newborns for Primary Prevention of Atopic Dermatitis

NCT07333378 | Not Yet Recruiting

• 2 other identifiers: 2306100011241933
• Study Type: interventional
• Target: 1,383
• Locations: 1 country
• Sites: 2

Brief Summary

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. 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. 2.Removal group: Vernix will be removed following current hospital practice using gentle cleaning with water and oil or petroleum jelly shortly after birth.

Conditions

Atopic Dermatitis

Keywords

vernix caseosa; primary prevention; newborn; eczema; atopic dermatitis; skin infections; Staphylococcus aureus

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (19)

• 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

Other Outcomes (7)

• Newborn temperature regulation

  0-24 hours of life

• Serious bacterial infections

  28 and 90 days of life

• Skin infections during infancy

  0-12 months

Study Arms (2)

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.

Other: Retention of Vernix Caseosa After Birth

Early removal of vernix caseosa

OTHER

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.

Other: Removal of Vernix Caseosa After Birth

Interventions

Retention of Vernix Caseosa After Birth OTHER

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.

Retain vernix caseosa

Removal of Vernix Caseosa After Birth OTHER

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.

Early removal of vernix caseosa

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (2)

Clínica San Carlos de Apoquindo

Las Condes, RM, Chile

Location

Hospital Clínico Universidad Católica

Santiago, RM, Chile

Location

Related Publications (29)

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MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Cellulitis; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Central Study Contacts

Arturo Borzutzky, M.D

CONTACT

+56223543753; aborzutz@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 12, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

CL (2)