NCT02570698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

September 30, 2015

Last Update Submit

August 15, 2017

Conditions

Diaper Dermatitis

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

AgeUp to 30 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants who are equal or less than a gestational age of 30 weeks + 4 days

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Related Publications (8)

  • 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.

    PMID: 20807257BACKGROUND

  • 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.

    PMID: 9699737BACKGROUND

  • 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.

    PMID: 8187514BACKGROUND

  • 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.

    PMID: 3513143BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 24224482BACKGROUND

  • 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.

    PMID: 25724911BACKGROUND

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, IrritantDermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Lawrence Eichenfield, MD

    UCSD Rady Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 7, 2015

Study Start

October 1, 2015

Primary Completion

December 7, 2016

Study Completion

January 23, 2017

Last Updated

August 18, 2017

Record last verified: 2017-08

Locations

US(1)