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Characterization of Pre-Term Neonatal Skin

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05127044
Enrollment
44
Registered
2021-11-19
Start date
2023-10-13
Completion date
2024-08-17
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Disorder

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.

DIAGNOSTIC_TESTBiliChek

BiliChek will be used as a control for determining bilirubin content.

Sponsors

University of Arkansas
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Hours to 6 Months
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

Design outcomes

Primary

MeasureTime frameDescription
Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek15 MinutesNumber 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

MeasureTime frameDescription
Hemoglobin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Valuesapproximately one day per subjectCompare 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 Valuesapproximately one day per subjectCompare 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 Valuesapproximately one day per subjectCompare 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

ArmCount
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
Total44

Baseline characteristics

CharacteristicQualified Preterm Infants
Age, Categorical
<=18 years
44 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous33.3 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 typeEG000
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

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.

Time frame: 15 Minutes

Population: All infants received the same testing method on each area of infant body

ArmMeasureValue (NUMBER)
Qualified Preterm Infants-ChestBilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek0.814386451 Correlation Coefficient R-Value
Qualified Preterm Infants-Upper ArmBilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek0.85422779 Correlation Coefficient R-Value
Qualified Preterm Infants-Outer ThighBilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek0.67588721 Correlation Coefficient R-Value
Qualified Preterm Infants- ForeheadBilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek0.79293382 Correlation Coefficient R-Value
Qualified Preterm Infant- Subject MeanBilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek0.86294585 Correlation Coefficient R-Value
Comparison: Power calculation located in Study Protocol-Correlation Coefficient-R Value
Comparison: Power calculation located in Study Protocol
Comparison: Power calculation located in Study Protocol
Comparison: Power calculation located in Study Protocol
Comparison: Power calculation located in Study Protocol
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.

Time frame: approximately one day per subject

ArmMeasureValue (MEAN)Dispersion
Qualified Preterm Infants-ChestBilirubin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values7.34 mg/dLStandard Deviation 3.91
p-value: 0.8203Linear correlation
p-value: 0.0001Linear correlation
p-value: 0.2156Regression, Linear
p-value: 0.0066Regression, Linear
p-value: 0.8203Regression, Linear
p-value: 0.0001Regression, Linear
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.

Time frame: approximately one day per subject

ArmMeasureValue (MEAN)Dispersion
Qualified Preterm Infants-ChestHemoglobin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values6.03 g/LStandard Deviation 0.843
p-value: 0.1544Linear correlation
p-value: 0.0087Linear correlation
p-value: 0.3038Regression, Linear
p-value: 0.6434Regression, Linear
p-value: 0.1544Regression, Linear
p-value: 0.0087Regression, Linear
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.

Time frame: approximately one day per subject

ArmMeasureValue (MEAN)Dispersion
Qualified Preterm Infants-ChestMelanin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values3.19 mg/dLStandard Deviation 1.24
p-value: 0.3143Linear correlation
p-value: 0.5914Linear correlation
p-value: 0.868Regression, Linear
p-value: 0.0001Regression, Linear
p-value: 0.3143Regression, Linear
p-value: 0.5914Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026