Clinical Trials Directory

Trials / Completed

CompletedNCT01619228

Skin Maturation in Premature Infants

Ontogeny of Skin Barrier Maturation in Premature Infants

Status
Completed
Phase
Study type
Observational
Enrollment
107 (actual)
Sponsor
Children's Hospital Medical Center, Cincinnati · Academic / Other
Sex
All
Age
24 Weeks – 43 Weeks
Healthy volunteers
Accepted

Summary

The skin barrier lipids will be lower in premature infants than in full term infants and will become normal over 3-4 months after birth. The higher skin pH in premature infants will be related to an altered lipid composition which will change as the skin acidifies.

Detailed description

Premature infants have a poor epidermal barrier with few cornified layers, putting them at significant risk for increased permeability to external agents, skin compromise, high water loss and infection. While the skin develops rapidly after birth upon exposure to the dry environment, the ontogeny of the skin maturation and the time to a fully functional and protective stratum corneum (SC) barrier is largely unknown. The impact of a poor skin barrier on nosocomial infections and the morbidity associated with prematurity is not well defined. The purpose is to evaluate skin barrier maturation in premature infants compared to full term infants. The skin barrier lipids will be lower in premature infants than in full term infants and will become normal over 3-4 months after birth. The higher skin surface acidity in premature infants will be related to an altered lipid composition which will change as the skin acidifies. Full thickness skin samples will be collected from premature and full term infants during the time of medically necessary surgical procedures for genomic/transcriptomics analyses. The gene profiles will be compared to the corresponding biomarker profiles to determine the relationship between genes and gene expression products, i.e., biomarkers. The genomic/transcriptomics, biomarker, instrumental and clinical assessments will be examined for relationships and compared between premature and full term cohorts.

Conditions

Timeline

Start date
2012-04-01
Primary completion
2015-03-01
Completion
2017-03-01
First posted
2012-06-14
Last updated
2020-02-10

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01619228. Inclusion in this directory is not an endorsement.