BM Collection From NICU Infants for Composition

Kimberly-Clark Corporation25 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diaper Dermatitis

Eligibility

Sex: ALLMax age: 30 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Rady Children's Hospital

San Diego, California, United States

Outcomes

Primary Outcomes

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

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.

Time frame: 0 to 5 weeks

Data from ClinicalTrials.gov

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