Clinical trial NCT02570698: BM Collection From NICU Infants for Composition
Official title: Collection and Characterization of Premature Infants Feces for Identification of Factors Contributing to Skin Irritation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaper Dermatitis
Lead sponsor: Kimberly-Clark Corporation
Sponsor class: INDUSTRY
First posted: 2015-10-07
Enrollment: 25
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants who are equal or less than a gestational age of 30 weeks + 4 days

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Composition of proteins (ug/uL) in premature infant feces
timeFrame: 0 to 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
Study officials:
affiliation: UCSD Rady Children's Hospital
name: Lawrence Eichenfield, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1046/j.1523-1747.1998.00289.x.
citation: 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. doi: 10.1111/j.1600-0536.1994.tb00696.x.
citation: Buckingham KW, Berg RW. Etiologic factors in diaper dermatitis: the role of feces. Pediatr Dermatol. 1986 Feb;3(2):107-12. doi: 10.1111/j.1525-1470.1986.tb00499.x.
citation: Visscher, Marty O. Recent advances in diaper dermatitis: etiology and treatment. Pediatric Health 3(1):81-98, 2009
citation: Visscher M, Narendran V. Neonatal Infant Skin: Development, Structure and Function. Newborn and Infant Nursing Review 14(4):135-141, 2014.
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.
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.