BM Collection From NICU Infants for Composition
Completed
- Conditions
- Diaper Dermatitis
- Registration Number
- NCT02570698
- Lead Sponsor
- Kimberly-Clark Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rady Children's Hospital
🇺🇸San Diego, California, United States