Characterization of Pre-Term Neonatal Skin

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Skin Disorder

Intervention / Treatment
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* Device: Diffuse Reflectance Spectroscopy
* Diagnostic Test: BiliChek


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Hours
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Qualified Preterm Infants<br>Preterm infants will receive non-invasive optical spectroscopy and transcutaneous bilirubin testing for baseline comparison | Device: Diffuse Reflectance Spectroscopy<br>* DRS will be used as a non-invasive optical spectroscopy method to collect key biological information from neonatal skin including skin maturity, blood oxygenation, and bilirubin content.<br>* Other names: DRS;Diagnostic Test: BiliChek<br>* BiliChek will be used as a control for determining bilirubin content.<br>* Other names: Transcutaneous Bilirubin Reading;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bilirubin concentration from non-invasive diffuse reflectance spectroscopy (DRS) vs BiliChek | Number of participants with premature skin will be assessed for study variable transcutaneous bilirubin readings using DRS system by comparing the measured bilirubin concentration levels using Diffuse Reflectance Spectroscopy (DRS) with readouts from the current UAMS practice standard (Philip's BiliChek) using a linear regression and a Pearson's correlation coefficient assessment. | approximately one day per subject | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin readings from diffuse reflectance spectroscopy (DRS) spectra compared with expected values | Compare hemoglobin readings from the DRS system's extracted spectra with expected values by gestational age using a linear regression and a Pearson's correlation coefficient assessment. | approximately one day per subject | 
| Melanin readings from diffuse reflectance spectroscopy (DRS) spectra compared with expected values | Compare melanin readings from the DRS system's extracted spectra with expected values by gestational age using a linear regression and a Pearson's correlation coefficient assessment. | approximately one day per subject | 
| Bilirubin readings from diffuse reflectance spectroscopy (DRS) spectra compared with expected values | Compare bilirubin readings from the DRS system's extracted spectra with expected values by gestational age using a linear regression and a Pearson's correlation coefficient assessment. | approximately one day per subject |