Characterization of Pre-Term Neonatal Skin

Skin Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05127044
• Other study ID #: 263337
• Status: Recruiting
• Start date: October 13, 2023
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: University of Arkansas
• Contact: Rebecca Sartini, DNP
• Phone: 501526-1580
• Email: rpsartini[@]uams.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Hours to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Skin Diseases
• Skin Disorder

Intervention

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.

Diagnostic Test:
• BiliChek
BiliChek will be used as a control for determining bilirubin content.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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.

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 M — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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