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.