Skin Disorder
Conditions
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.
Interventions
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.
BiliChek will be used as a control for determining bilirubin content.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek | 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
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values | approximately one day per subject | 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. |
| Melanin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values | approximately one day per subject | 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. |
| Bilirubin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values | approximately one day per subject | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Qualified Preterm Infants |
|---|---|
| Age, Categorical <=18 years | 44 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 33.3 Gestational Age in Weeks |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 44 |
| other Total, other adverse events | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
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.
Time frame: 15 Minutes
Population: All infants received the same testing method on each area of infant body
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Qualified Preterm Infants-Chest | Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek | 0.814386451 Correlation Coefficient R-Value |
| Qualified Preterm Infants-Upper Arm | Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek | 0.85422779 Correlation Coefficient R-Value |
| Qualified Preterm Infants-Outer Thigh | Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek | 0.67588721 Correlation Coefficient R-Value |
| Qualified Preterm Infants- Forehead | Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek | 0.79293382 Correlation Coefficient R-Value |
| Qualified Preterm Infant- Subject Mean | Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek | 0.86294585 Correlation Coefficient R-Value |
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.
Time frame: approximately one day per subject
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Qualified Preterm Infants-Chest | Bilirubin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values | 7.34 mg/dL | Standard Deviation 3.91 |
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.
Time frame: approximately one day per subject
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Qualified Preterm Infants-Chest | Hemoglobin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values | 6.03 g/L | Standard Deviation 0.843 |
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.
Time frame: approximately one day per subject
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Qualified Preterm Infants-Chest | Melanin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values | 3.19 mg/dL | Standard Deviation 1.24 |