BM Collection From NICU Infants for Composition

Kimberly-Clark

Status: Completed

Conditions: Diaper Dermatitis

Study type: Observational

Funder types: Industry

Identifiers

NCT02570698

500-15-0001

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: Under 30 weeks old

Volunteers: Accepts Healthy Volunteers

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.