Clinical Trial: BM Collection From NICU Infants for Composition

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Collection and Characterization of Premature Infants Feces for Identification of Factors Contributing to Skin Irritation

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 Summary:
Sponsor: Kimberly-Clark Corporation

Current Primary Outcome: Composition of proteins (ug/uL) in premature infant feces [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Kimberly-Clark Corporation

Dates:
Date Received: September 30, 2015
Date Started: October 2015
Date Completion: March 2017
Last Updated: February 28, 2017
Last Verified: February 2017