Diaper Dermatitis
Conditions
Brief summary
The primary objective of this study is to collect feces from premature infants over a five weeks period to characterize its composition. Metabolomics, Proteomics, Genomics and Microbiome analyses and cell-based assays will be performed to identify individual components present in feces, which may contribute to the onset of irritation in the diapered area of premature infants.
Interventions
None listed
Sponsors
Kimberly-Clark Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Infant's parent(s)/legal guardian(s) must be fluent in English or Spanish, willing and able to read, understand, and sign the informed consent form (ICF). * Infants (male or female) who are equal or less than a gestational age of 30 weeks + 4 days.
Exclusion criteria
* Any medical condition which, in the opinion of the principal investigator, may compromise infant's safety. * Any underlying chronic skin conditions. However, infants may participate in the study with a rash in the diapered area if, in the opinion of the principal investigator, this does not compromise infant's safety.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composition of proteins (ug/uL) in premature infant feces | 0 to 5 weeks | This is an observational study where fecal samples will be collected twice each week for 5 weeks from enrolled patients. Primary analysis will consist of identification and quantification proteins present in samples. |
Countries
United States
Outcome results
None listed