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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qualified Preterm Infants | Other | The skin of preterm neonates will be analyzed with diffuse reflectance spectroscopy (DRS) and Philip's BiliChek transcutaneous bilirubin testing for baseline comparison |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffuse Reflectance Spectroscopy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek | 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. | 15 Minutes |
| 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, race, ethnicity, and sex using a linear regression and a Pearson's correlation coefficient assessment. | approximately one day per subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Sartini, DNP | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Jacques, S.L., D.G. Oelberg, and I. Saidi, Method and apparatus for optical measurement of bilirubin in tissue. 1994, Board of Regents, The University of Texas System: United States. | ||
| 19758381 | Result | Afsar FS. Physiological skin conditions of preterm and term neonates. Clin Exp Dermatol. 2010 Jun;35(4):346-50. doi: 10.1111/j.1365-2230.2009.03562.x. Epub 2009 Sep 15. | |
| 11886508 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Qualified Preterm Infants | Preterm infants will receive non-invasive optical spectroscopy and transcutaneous bilirubin testing for baseline comparison Diffuse Reflectance Spectroscopy: 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. BiliChek: BiliChek will be used as a control for determining bilirubin content. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Qualified Preterm Infants | Preterm infants will receive non-invasive optical spectroscopy and transcutaneous bilirubin testing for baseline comparison Diffuse Reflectance Spectroscopy: 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. BiliChek: BiliChek will be used as a control for determining bilirubin content. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek | 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. | All infants received the same testing method on each area of infant body | Posted | Number | Correlation Coefficient R-Value | 15 Minutes |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Qualified Preterm Infants | Preterm infants will receive non-invasive optical spectroscopy and transcutaneous bilirubin testing for baseline comparison Diffuse Reflectance Spectroscopy: 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. BiliChek: BiliChek will be used as a control for determining bilirubin content. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca P Sartini, DNP | University of Arkansas for Medical Sciences | 5015261580 | rpsartini@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2023 | Aug 12, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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|
| BiliChek | Diagnostic Test | BiliChek will be used as a control for determining bilirubin content. |
|
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| 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, race, ethnicity, and sex 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, race, ethnicity, and sex using a linear regression and a Pearson's correlation coefficient assessment. | approximately one day per subject |
| Result |
| Zonios G, Bykowski J, Kollias N. Skin melanin, hemoglobin, and light scattering properties can be quantitatively assessed in vivo using diffuse reflectance spectroscopy. J Invest Dermatol. 2001 Dec;117(6):1452-7. doi: 10.1046/j.0022-202x.2001.01577.x. |
| 16526895 | Result | Subhash N, Mallia JR, Thomas SS, Mathews A, Sebastian P, Madhavan J. Oral cancer detection using diffuse reflectance spectral ratio R540/R575 of oxygenated hemoglobin bands. J Biomed Opt. 2006 Jan-Feb;11(1):014018. doi: 10.1117/1.2165184. |
| 20482289 | Result | Qualter YM, Allen NM, Corcoran JD, O'Donovan DJ. Transcutaneous bilirubin--comparing the accuracy of BiliChek(R) and JM 103(R) in a regional postnatal unit. J Matern Fetal Neonatal Med. 2011 Feb;24(2):267-70. doi: 10.3109/14767058.2010.484471. Epub 2010 May 19. |
| 19021373 | Result | Rajaram N, Nguyen TH, Tunnell JW. Lookup table-based inverse model for determining optical properties of turbid media. J Biomed Opt. 2008 Sep-Oct;13(5):050501. doi: 10.1117/1.2981797. |
| Participants |
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| Age, Continuous | Mean | Full Range | Gestational Age in Weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Qualified Preterm Infants | Number | participants |
|
| OG001 | Qualified Preterm Infants-Upper Arm | Preterm infants received non-invasive optical spectroscopy and transcutaneous bilirubin testing for baseline comparison Diffuse Reflectance Spectroscopy: DRS used as a non-invasive optical spectroscopy method to collect key biological information from neonatal skin: Upper Arm BiliChek: BiliChek will be used as a control for determining bilirubin content. |
| OG002 | Qualified Preterm Infants-Outer Thigh | Preterm infants received non-invasive optical spectroscopy and transcutaneous bilirubin testing for baseline comparison Diffuse Reflectance Spectroscopy: DRS used as a non-invasive optical spectroscopy method to collect key biological information from neonatal skin: Outer Thigh BiliChek: BiliChek will be used as a control for determining bilirubin content. |
| OG003 | Qualified Preterm Infants- Forehead | Preterm infants received non-invasive optical spectroscopy and transcutaneous bilirubin testing for baseline comparison Diffuse Reflectance Spectroscopy: DRS used as a non-invasive optical spectroscopy method to collect key biological information from neonatal skin: Forehead BiliChek: BiliChek will be used as a control for determining bilirubin content. |
| OG004 | Qualified Preterm Infant- Subject Mean | Preterm infants received non-invasive optical spectroscopy and transcutaneous bilirubin testing for baseline comparison Diffuse Reflectance Spectroscopy: DRS used as a non-invasive optical spectroscopy method to collect key biological information from neonatal skin: Mean Analysis BiliChek: BiliChek will be used as a control for determining bilirubin content |
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| Secondary | 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, race, ethnicity, and sex using a linear regression and a Pearson's correlation coefficient assessment. | Posted | Mean | Standard Deviation | g/L | approximately one day per subject |
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| Secondary | 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, race, ethnicity, and sex using a linear regression and a Pearson's correlation coefficient assessment. | Posted | Mean | Standard Deviation | mg/dL | approximately one day per subject |
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| Secondary | 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, race, ethnicity, and sex using a linear regression and a Pearson's correlation coefficient assessment. | Posted | Mean | Standard Deviation | mg/dL | approximately one day per subject |
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| 44 |
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| 44 |
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| 0.0087 |
| Pearson Correlation Coefficient |
| 0.3909 |
| Other |
Pearson's correlation coefficient was calculated to assess the relationship between hemoglobin concentration and gestational age. |
| Regression, Linear | 0.3038 | Coefficient of determination | 0.0252 | 2-Sided | Other | A simple linear regression model was fitted with hemoglobin concentration as the dependent variable and sex as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²). |
| Regression, Linear | 0.6434 | Coefficient of determination | 0.0213 | 2-Sided | Other | A simple linear regression model was fitted with hemoglobin concentration as the dependent variable and ethnicity as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²). |
| Regression, Linear | 0.1544 | Coefficient of determination | 0.0477 | 2-Sided | Other | A simple linear regression model was fitted with hemoglobin concentration as the dependent variable and weight as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²). |
| Regression, Linear | 0.0087 | Coefficient of determination | 0.1528 | 2-Sided | Other | A simple linear regression model was fitted with hemoglobin concentration as the dependent variable and gestational age as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²). |
| 0.5914 |
| Pearson Correlation Coefficient |
| -0.0832 |
| 2-Sided |
| Other |
Pearson's correlation coefficient was calculated to assess the relationship between melanin concentration and gestational age. |
| Regression, Linear | 0.868 | Coefficient of determination | 0.000665 | 2-Sided | Other | A simple linear regression model was fitted with melanin concentration as the dependent variable and sex as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²). |
| Regression, Linear | 0.0001 | Coefficient of determination | 0.574 | 2-Sided | Other | A simple linear regression model was fitted with melanin concentration as the dependent variable and ethnicity as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²). |
| Regression, Linear | 0.3143 | Coefficient of determination | 0.0241 | 2-Sided | Other | A simple linear regression model was fitted with melanin concentration as the dependent variable and weight as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²). |
| Regression, Linear | 0.5914 | Coefficient of determination | 0.0069 | 2-Sided | Other | A simple linear regression model was fitted with melanin concentration as the dependent variable and gestational age as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²). |
| 0.0001 |
| Pearson Correlation Coefficient |
| 0.595 |
| 2-Sided |
| Other |
Pearson's correlation coefficient was calculated to assess the relationship between bilirubin concentration and gestational age. |
| Regression, Linear | 0.2156 | Coefficient of determination | 0.0363 | 2-Sided | Other | A simple linear regression model was fitted with melanin concentration as the dependent variable and sex as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²). |
| Regression, Linear | 0.0066 | Coefficient of determination | 0.2172 | 2-Sided | Other | A simple linear regression model was fitted with melanin concentration as the dependent variable and ethnicity as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²). |
| Regression, Linear | 0.8203 | Coefficient of determination | 0.00124 | 2-Sided | Other | A simple linear regression model was fitted with melanin concentration as the dependent variable and weight as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²). |
| Regression, Linear | 0.0001 | Coefficient of determination | 0.354 | 2-Sided | Other | A simple linear regression model was fitted with melanin concentration as the dependent variable and gestational age as the independent predictor. The strength of the relationship was evaluated using the coefficient of determination (R²). |