Trial Outcomes & Findings for Characterization of Pre-Term Neonatal Skin (NCT NCT05127044)

Last Updated: 2025-11-13

Results Overview

Number of participants with premature skin 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

15 Minutes

Results posted on

2025-11-13

Participant Flow

Participant milestones

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

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=10 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants
Age, Continuous	33.3 Gestational Age in Weeks n=10 Participants
Sex: Female, Male Female	17 Participants n=10 Participants
Sex: Female, Male Male	27 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	15 Participants n=10 Participants
Race (NIH/OMB) White	27 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=10 Participants
Region of Enrollment United States	44 participants n=10 Participants

PRIMARY outcome

Timeframe: 15 Minutes

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

Outcome measures

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 subject

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.

Outcome measures

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	—	—	—	—

SECONDARY outcome

Timeframe: approximately one day per subject

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.

Outcome measures

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	—	—	—	—

SECONDARY outcome

Timeframe: approximately one day per subject

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.

Outcome measures

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	—	—	—	—

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