Characterization of Pre-Term Neonatal Skin

NCT05127044 | Completed Results FDA Device

• 1 other identifier: 263337
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The skin of pre-term neonates is not fully developed and often leads to trans-epidermal water loss, trouble regulating temperature, and increased risk of skin wounds. Current treatment decisions are based on subjective, qualitative assessments of the skin. The purpose of this pilot study is to evaluate the utility of non-invasive optical spectroscopy methods to collect key biological information from neonatal skin, including skin maturity, blood oxygenation, and bilirubin content. Parents of pre-term neonatal subjects (n=44) will be recruited for consent to participate, and spectral measurements will be made with a diffuse reflectance spectrometer(DRS) device previously approved by the University of Arkansas for Medical Sciences Institutional Review Board. The spectral data will be analyzed to extract parameters related to tissue light scattering, oxy-and deoxy-hemoglobin, melanin, and bilirubin. The system will be validated by comparing extracted spectra with expected literature values and directly correlating the measured bilirubin levels with readouts from the current University of Arkansas for Medical Sciences practice standard: Philip's BiliChek. The long-term goal is to develop and use non-invasive optical readouts to predict and monitor skin dysfunction in the Neonatal Intensive Care Unit (NICU).

Conditions

Skin Disorder

Outcome Measures

Primary Outcomes (1)

• Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek

  Number of participants with premature skin assessed with Diffuse Reflectance Spectroscopy, comparing bilirubin concentration levels/readings produced by DRS system with readouts from the current UAMS practice standard (Philip's BiliChek) using a linear regression and a Pearson's correlation coefficient assessment.

  15 Minutes

Secondary Outcomes (3)

• Hemoglobin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values

  approximately one day per subject

• Melanin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values

  approximately one day per subject

• Bilirubin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values

  approximately one day per subject

Study Arms (1)

Qualified Preterm Infants

OTHER

The skin of preterm neonates will be analyzed with diffuse reflectance spectroscopy (DRS) and Philip's BiliChek transcutaneous bilirubin testing for baseline comparison

Device: Diffuse Reflectance Spectroscopy; Diagnostic Test: BiliChek

Interventions

Diffuse Reflectance Spectroscopy DEVICE

DRS will be used as a non-invasive optical spectroscopy method to evaluate whether DRS spectra can be used to extract optical information related to skin maturity as well as hemoglobin, melanin, and bilirubin concentrations.

Also known as: DRS

Qualified Preterm Infants

BiliChek DIAGNOSTIC_TEST

BiliChek will be used as a control for determining bilirubin content.

Also known as: Transcutaneous Bilirubin Reading

Qualified Preterm Infants

Eligibility Criteria

• Age: 24 Hours - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants less than or equal to 37 weeks gestation at birth
• Current care provided by the UAMS NICU

You may not qualify if:

• Infants entering palliative care
• Infants with known liver disease
• Infants on isolation precautions
• Infants at end of life
• On minimal stimulation protocol
• Any other condition, that in the opinion of the investigator, might interfere with the safe conduct of the study or place the subject at increased risk

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (6)

• Jacques, S.L., D.G. Oelberg, and I. Saidi, Method and apparatus for optical measurement of bilirubin in tissue. 1994, Board of Regents, The University of Texas System: United States.

  BACKGROUND

• Afsar FS. Physiological skin conditions of preterm and term neonates. Clin Exp Dermatol. 2010 Jun;35(4):346-50. doi: 10.1111/j.1365-2230.2009.03562.x. Epub 2009 Sep 15.

  PMID: 19758381 RESULT

• Zonios G, Bykowski J, Kollias N. Skin melanin, hemoglobin, and light scattering properties can be quantitatively assessed in vivo using diffuse reflectance spectroscopy. J Invest Dermatol. 2001 Dec;117(6):1452-7. doi: 10.1046/j.0022-202x.2001.01577.x.

  PMID: 11886508 RESULT

• Subhash N, Mallia JR, Thomas SS, Mathews A, Sebastian P, Madhavan J. Oral cancer detection using diffuse reflectance spectral ratio R540/R575 of oxygenated hemoglobin bands. J Biomed Opt. 2006 Jan-Feb;11(1):014018. doi: 10.1117/1.2165184.

  PMID: 16526895 RESULT

• Qualter YM, Allen NM, Corcoran JD, O'Donovan DJ. Transcutaneous bilirubin--comparing the accuracy of BiliChek(R) and JM 103(R) in a regional postnatal unit. J Matern Fetal Neonatal Med. 2011 Feb;24(2):267-70. doi: 10.3109/14767058.2010.484471. Epub 2010 May 19.

  PMID: 20482289 RESULT

• Rajaram N, Nguyen TH, Tunnell JW. Lookup table-based inverse model for determining optical properties of turbid media. J Biomed Opt. 2008 Sep-Oct;13(5):050501. doi: 10.1117/1.2981797.

  PMID: 19021373 RESULT

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Rebecca P Sartini, DNP
• Organization: University of Arkansas for Medical Sciences

rpsartini@uams.edu

5015261580

Study Officials

• Rebecca Sartini, DNP

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 19, 2021
• Study Start: October 13, 2023
• Primary Completion: August 17, 2024
• Study Completion: August 17, 2024
• Last Updated: November 26, 2025
• Results First Posted: October 22, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)