Trial Outcomes & Findings for Characterization of Pre-Term Neonatal Skin (NCT NCT05127044)
NCT ID: NCT05127044
Last Updated: 2025-11-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
15 Minutes
Results posted on
2025-11-26
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Characterization of Pre-Term Neonatal Skin
Baseline characteristics by cohort
| Measure |
Qualified Preterm Infants
n=44 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
44 Participants
n=492 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=492 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=492 Participants
|
|
Age, Continuous
|
33.3 Gestational Age in Weeks
n=492 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=492 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=492 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=492 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=492 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=492 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=492 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=492 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=492 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=492 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=492 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=492 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=492 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=492 Participants
|
PRIMARY outcome
Timeframe: 15 MinutesPopulation: All infants received the same testing method on each area of infant body
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.
Outcome measures
| Measure |
Qualified Preterm Infants-Chest
n=44 Participants
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: Chest
BiliChek: BiliChek will be used as a control for determining bilirubin content.
|
Qualified Preterm Infants-Upper Arm
n=44 Participants
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.
|
Qualified Preterm Infants-Outer Thigh
n=44 Participants
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.
|
Qualified Preterm Infants- Forehead
n=44 Participants
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.
|
Qualified Preterm Infant- Subject Mean
n=44 Participants
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
|
|---|---|---|---|---|---|
|
Bilirubin Concentration From Non-invasive Diffuse Reflectance Spectroscopy (DRS) vs BiliChek
|
0.814386451 Correlation Coefficient R-Value
|
0.85422779 Correlation Coefficient R-Value
|
0.67588721 Correlation Coefficient R-Value
|
0.79293382 Correlation Coefficient R-Value
|
0.86294585 Correlation Coefficient R-Value
|
SECONDARY outcome
Timeframe: approximately 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.
Outcome measures
| Measure |
Qualified Preterm Infants-Chest
n=44 Participants
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: Chest
BiliChek: BiliChek will be used as a control for determining bilirubin content.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|
|
Hemoglobin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values
|
6.03 g/L
Standard Deviation 0.843
|
—
|
—
|
—
|
—
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SECONDARY outcome
Timeframe: approximately 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.
Outcome measures
| Measure |
Qualified Preterm Infants-Chest
n=44 Participants
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: Chest
BiliChek: BiliChek will be used as a control for determining bilirubin content.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|
|
Melanin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values
|
3.19 mg/dL
Standard Deviation 1.24
|
—
|
—
|
—
|
—
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SECONDARY outcome
Timeframe: approximately 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.
Outcome measures
| Measure |
Qualified Preterm Infants-Chest
n=44 Participants
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: Chest
BiliChek: BiliChek will be used as a control for determining bilirubin content.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|
|
Bilirubin Readings From Diffuse Reflectance Spectroscopy (DRS) Spectra Compared With Expected Values
|
7.34 mg/dL
Standard Deviation 3.91
|
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Adverse Events
Qualified Preterm Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rebecca P Sartini, DNP
University of Arkansas for Medical Sciences
Phone: 5015261580
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place