N/A
N=44
Characterization of Pre-Term Neonatal Skin
Skin Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05127044 ↗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
| Outcome | Result | p-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
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.