BM Collection From NICU Infants for Composition

Completed

Conditions studied: Diaper Dermatitis

In brief

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.

Key facts

Study ID

NCT02570698

Run by

Kimberly-Clark Corporation

People needed

25

Starts

2015-10-01

Expected to finish

2017-01-23

Last updated by the study team

2017-08-18

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rady Children's Hospital — San Diego, California, United States

Full record on ClinicalTrials.gov

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