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OpenTrials
Completed

NCT Number: NCT02570698

BM Collection From NICU Infants for Composition

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.

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Key information

Conditions

Diaper Dermatitis Dermatitis Dermatitis, Contact Dermatitis, Irritant Diaper Rash Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

Up to 30 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Rady Children's Hospital

San Diego, California, 92123, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kimberly-Clark Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 7, 2015
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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