Characterization of Pre-Term Neonatal Skin by Diffuse Reflectance Spectroscopy Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Arkansas
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek
Study Overview
Brief 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).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 24 Hours to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Qualified Preterm Infants
The skin of preterm neonates will be analyzed with diffuse reflectance spectroscopy (DRS) and Philip's BiliChek transcutaneous bilirubin testing for baseline comparison
Intervention: Diffuse Reflectance Spectroscopy (Device)
Qualified Preterm Infants
The skin of preterm neonates will be analyzed with diffuse reflectance spectroscopy (DRS) and Philip's BiliChek transcutaneous bilirubin testing for baseline comparison
Intervention: BiliChek (Diagnostic Test)
Outcomes
Primary Outcomes
Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek
Time Frame: 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.
Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek
Time Frame: 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.
Secondary Outcomes
- Hemoglobin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values(approximately one day per subject)
- Melanin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values(approximately one day per subject)
- Bilirubin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values(approximately one day per subject)
- Hemoglobin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values(approximately one day per subject)
- Melanin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values(approximately one day per subject)
- Bilirubin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values(approximately one day per subject)