Characterization of Pre-Term Neonatal Skin

Characterization of Pre-Term Neonatal Skin by Diffuse Reflectance Spectroscopy Pilot Study

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).

Study Overview

• Status: Recruiting
• Conditions: Skin Disorder
• Intervention / Treatment: Device: Diffuse Reflectance Spectroscopy; Diagnostic test: BiliChek

Detailed Description

This is a cross-sectional, pilot study to characterize the response of neonatal premature skin to DRS when excited with a white light source, and provide a baseline of how the collected spectra change with the maturation of the epidermal layer in the weeks to term gestation after birth. DRS spectra and BiliChek measurements will be performed on the study population admitted to the Neonatal Intensive Care Unit. The pilot data will be used to evaluate whether Diffuse Reflectance Spectroscopy spectra can be used to extract optical information on skin maturity as well as hemoglobin, melanin, and bilirubin concentrations. The investigators will extract spectra for each chromophore and the relative concentration from the Diffuse Reflectance Spectroscopy measurements. Extracted Diffuse Reflectance Spectroscopy spectra will be compared to published absorbance spectra for each chromophore. The criteria for success will be a high, positive correlation (r ≥ 0.85) between the extracted Diffuse Reflectance Spectroscopy bilirubin concentration and BiliChek-derived concentration.

The following coded data will also be collected to investigate correlations with the Diffuse Reflectance Spectroscopy spectra: blood oxygen saturation, weight, ethnicity, corrected age, gestational age, sex, most recent complete blood count (if available, or partial count if not), most recent chemistry levels, lipids, liver profile, and blood gas (all if available). BiliChek measurements of bilirubin content will be compared to the extracted bilirubin contribution measured from the Diffuse Reflectance Spectroscopy spectra using linear regression and assessed using Pearson's correlation coefficient.

• Study Type: Observational
• Enrollment (Estimated): 44

Contacts and Locations

• Study Contact: Name: Rebecca Sartini, DNP; Phone Number: 501526-1580; Email: rpsartini@uams.edu
• Study Contact Backup: Name: Kyle Quinn, PhD; Phone Number: 4795735384; Email: kpquinn@uark.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • University of Arkansas for Medical Sciences
      • Contact: Rebecca Sartini, DNP; Phone Number: 501-526-1580; Email: rpsartini@uams.edu
      • Contact: Rebecca Smith, MSN; Phone Number: Sartini 5015261500; Email: rpsartini@uams.edu
      • Principal Investigator: Rebecca Sartini, DNP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 6 months (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Study population to include premature infants less than 37 weeks gestation meeting born at University of Arkansas for Medical Sciences admitted to the NICU.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Qualified Preterm Infants; Preterm infants will receive non-invasive optical spectroscopy and transcutaneous bilirubin testing for baseline comparison	Device: Diffuse Reflectance Spectroscopy; DRS will be used as a non-invasive optical spectroscopy method to collect key biological information from neonatal skin including skin maturity, blood oxygenation, and bilirubin content.; Other Names: DRS; Diagnostic test: BiliChek; BiliChek will be used as a control for determining bilirubin content.; Other Names: Transcutaneous Bilirubin Reading

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bilirubin concentration from non-invasive diffuse reflectance spectroscopy (DRS) vs BiliChek	Number of participants with premature skin will be assessed for study variable transcutaneous bilirubin readings using DRS system by comparing the measured bilirubin concentration levels using Diffuse Reflectance Spectroscopy (DRS) with readouts from the current UAMS practice standard (Philip's BiliChek) using a linear regression and a Pearson's correlation coefficient assessment.	approximately one day per subject

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin readings from diffuse reflectance spectroscopy (DRS) spectra compared with expected values	Compare hemoglobin readings from the DRS system's extracted spectra with expected values by gestational age using a linear regression and a Pearson's correlation coefficient assessment.	approximately one day per subject
Melanin readings from diffuse reflectance spectroscopy (DRS) spectra compared with expected values	Compare melanin readings from the DRS system's extracted spectra with expected values by gestational age using a linear regression and a Pearson's correlation coefficient assessment.	approximately one day per subject
Bilirubin readings from diffuse reflectance spectroscopy (DRS) spectra compared with expected values	Compare bilirubin readings from the DRS system's extracted spectra with expected values by gestational age using a linear regression and a Pearson's correlation coefficient assessment.	approximately one day per subject

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Rebecca Sartini, DNP, University of Arkansas

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Bilirubin
• Other Study ID Numbers: 263337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes