Retention of Vernix Caseosa in Newborns for Primary Prevention of Atopic Dermatitis
A legfontosabb adatok
- Ki végzi
- Pontificia Universidad Catolica de Chile
- Hol
- Las Condes és Santiago (Chile)Mind a 2 helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 1383 fő, tervezett
- Kezdés
- 2026. szept. 29.
- Várható befejezés
- 2028. márc. 31.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoport
- A vizsgált kezelések
- Retention of Vernix Caseosa After Birth
- Removal of Vernix Caseosa After Birth
- A regiszteradat frissítve
- 2026. szeptember 30.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan 18 éves vagy idősebb várandós nőket keres, akik egy résztvevő kórházban egészséges, egyke újszülöttet szülnek. A vizsgálat azt teszi próbára, mi történik, ha a születés után a fehér bevonatot (vernix) a baba bőrén hagyják.
- Életkor
- Az anya 18 éves vagy idősebb; a baba újszülött (0 napostól).
- Nem
- Minden nem részt vehet.
A részvétel fő kizáró okai
- A baba születési súlya kevesebb mint 2000 g
- A baba a terhesség 34. hete előtt született
- Ikrek vagy más soktöbbes szülés
- Az anya HIV-pozitív
- Chorioamnionitis (a magzatburok fertőzése) igazolt vagy gyanított
Ez a vizsgálat csak várandós résztvevőket keres. A regiszter mondata, amelyen ez alapul: pregnant mother aged 18 and older, who is able to provide informed consent for participation
A regiszter feltételei, szó szerint
Mind a 10 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- maternal HIV-positivity
- 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)
- clinical and/or laboratory diagnosis of chorioamnionitis
- prematurity younger than 34 weeks of gestation
- birthweight <2000 g
- multiple gestation / multiple births
Helyszínek itt: Chile
- Clínica San Carlos de ApoquindoLas Condes, ChileContact: Arturo Borzutzky, M.D.Toborzás még nem indult
- Hospital Clínico Universidad CatólicaSantiago, ChileContact: Arturo Borzutzky, M.D.Résztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- Retain vernix caseosaA vizsgált kezelés
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.
Kezelés: Retention of Vernix Caseosa After Birth
- Early removal of vernix caseosaEgyéb csoport
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.
Kezelés: Removal of Vernix Caseosa After Birth
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Post-partum Retention of Vernix Caseosa for Primary Prevention of Atopic Dermatitis, Guarding Skin Integrity and Fostering a Healthy Microbiome.
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 13.
- A regiszteradat frissítve
- 2026. szeptember 30.