Adults 24 Hours to 6 Months, any sex, with Skin Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChekPrimary· 15 Minutes
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.
Group
Value
95% CI
Qualified Preterm Infants-Chest
0.814386451
Qualified Preterm Infants-Upper Arm
0.85422779
Qualified Preterm Infants-Outer Thigh
0.67588721
Qualified Preterm Infants- Forehead
0.79293382
Qualified Preterm Infant- Subject Mean
0.86294585
Hemoglobin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected ValuesSecondary· approximately one day per subject
Compare hemoglobin readings from the DRS system's extracted spectra with expected values by gestational age, race, ethnicity, and sex using a linear regression and a Pearson's correlation coefficient assessment.
Group
Value
95% CI
Qualified Preterm Infants
6.03
± 0.843
Melanin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected ValuesSecondary· approximately one day per subject
Compare melanin readings from the DRS system's extracted spectra with expected values by gestational age, race, ethnicity, and sex using a linear regression and a Pearson's correlation coefficient assessment.
Group
Value
95% CI
Qualified Preterm Infants
3.19
± 1.24
Bilirubin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected ValuesSecondary· approximately one day per subject
Compare bilirubin readings from the DRS system's extracted spectra with expected values by gestational age, race, ethnicity, and sex using a linear regression and a Pearson's correlation coefficient assessment.
Group
Value
95% CI
Qualified Preterm Infants
7.34
± 3.91
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Arkansas
Last refreshed: 26 November 2025
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