CompletedNot Applicable

BM Collection From NICU Infants for Composition

United States25 participantsStarted 2015-10

Plain-language 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.

Who can participate

Age range30 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Composition of proteins (ug/uL) in premature infant feces

Timeframe: 0 to 5 weeks

Trial details

NCT IDNCT02570698

SponsorKimberly-Clark Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-12-07

View on ClinicalTrials.gov More Diaper Dermatitis trials