CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Diffuse Reflectance Spectroscopy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05127044
NCT05127044N/ACompleted

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

University of Arkansas·interventional·Posted Nov 19, 2021·Updated Nov 26, 2025

In Brief

A clinical study evaluating Diffuse Reflectance Spectroscopy and BiliChek for Skin Disorder. Completed, enrolled 44 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Disorder
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedNov 19, 2021
Enrollment StartOct 13, 2023
Primary CompletionAug 17, 2024
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.6 years ago

Interventions

Diffuse Reflectance Spectroscopydevice

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.

BiliChekother

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