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N/A N=44 Basic Science

Characterization of Pre-Term Neonatal Skin

Skin Disorder

Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek — 0.814386451; 0.85422779; 0.67588721; 0.79293382 Correlation Coefficient R-Value

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Diffuse Reflectance Spectroscopy (Device); BiliChek (Diagnostic_test)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
University of Arkansas
Primary completion
Aug 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek
0.814386451; 0.85422779; 0.67588721; 0.79293382; 0.86294585
SECONDARY
Hemoglobin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values
6.03 0.1544
SECONDARY
Melanin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values
3.19 0.3143
SECONDARY
Bilirubin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values
7.34 0.8203

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).

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05127044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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