BM Collection From NICU Infants for Composition

Diaper Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570698
• Other study ID #: 500-15-0001
• Status: Completed
• Phase: N/A
• First received: September 30, 2015
• Last updated: August 15, 2017
• Start date: October 2015
• Est. completion date: January 23, 2017

Study information

• Verified date: August 2017
• Source: Kimberly-Clark Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 23, 2017
• Est. primary completion date: December 7, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 30 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Diaper Dermatitis
• Diaper Rash

Locations

Country	Name	City	State
United States	Rady Children's Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Kimberly-Clark Corporation

Country where clinical trial is conducted

United States, 

References & Publications (8)

Andersen PH, Bucher AP, Saeed I, Lee PC, Davis JA, Maibach HI. Faecal enzymes: in vivo human skin irritation. Contact Dermatitis. 1994 Mar;30(3):152-8. — View Citation

Bruderer R, Bernhardt OM, Gandhi T, Miladinovic SM, Cheng LY, Messner S, Ehrenberger T, Zanotelli V, Butscheid Y, Escher C, Vitek O, Rinner O, Reiter L. Extending the limits of quantitative proteome profiling with data-independent acquisition and application to acetaminophen-treated three-dimensional liver microtissues. Mol Cell Proteomics. 2015 May;14(5):1400-10. doi: 10.1074/mcp.M114.044305. Epub 2015 Feb 27. — View Citation

Buckingham KW, Berg RW. Etiologic factors in diaper dermatitis: the role of feces. Pediatr Dermatol. 1986 Feb;3(2):107-12. — View Citation

Kalia YN, Nonato LB, Lund CH, Guy RH. Development of skin barrier function in premature infants. J Invest Dermatol. 1998 Aug;111(2):320-6. — View Citation

Stamatas GN, Nikolovski J, Mack MC, Kollias N. Infant skin physiology and development during the first years of life: a review of recent findings based on in vivo studies. Int J Cosmet Sci. 2011 Feb;33(1):17-24. doi: 10.1111/j.1468-2494.2010.00611.x. Epub 2010 Aug 30. Review. — View Citation

Stamatas GN, Tierney NK. Diaper dermatitis: etiology, manifestations, prevention, and management. Pediatr Dermatol. 2014 Jan-Feb;31(1):1-7. doi: 10.1111/pde.12245. Epub 2013 Nov 14. Review. — View Citation

Visscher M, Narendran V. Neonatal Infant Skin: Development, Structure and Function. Newborn and Infant Nursing Review 14(4):135-141, 2014.

Visscher, Marty O. Recent advances in diaper dermatitis: etiology and treatment. Pediatric Health 3(1):81-98, 2009

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0 to 5 weeks