Retention of vernix caseosa after birth to help prevent eczema in newborns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores a primary prevention approach for atopic dermatitis by modifying newborn skin care at birth. Two strategies are compared: retaining vernix caseosa on the skin versus removing it after birth. The trial enrolls healthy, singleton newborns delivered at participating Chilean hospitals and follows standard postoperative and neonatal care schedules to monitor skin barrier function and early signs of eczema. The rationale is that vernix contains protective lipids and antimicrobial components that might support skin barrier integrity during a critical window of immune development. Results will inform whether vernix retention could be a feasible, low-cost strategy to reduce the burden of atopic dermatitis in early childhood.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Where it's running

• Hospital Clínico Universidad Católica
  Santiago, Rm, Chile Recruiting
• Clínica San Carlos de Apoquindo
  Las Condes, Rm, Chile Not yet recruiting

Study contacts

• Study coordinator: Arturo Borzutzky, M.D
• Email: aborzutz@uc.cl
• Phone: +56223543753

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.