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Characterization of Pre-Term Neonatal Skin

NCT ID: NCT05127044

Last Updated: 2025-11-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-13

Study Completion Date

2024-08-17

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Skin Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Qualified Preterm Infants

Preterm infants will receive non-invasive optical spectroscopy and transcutaneous bilirubin testing for baseline comparison

Group Type OTHER

Diffuse Reflectance Spectroscopy

Intervention Type DEVICE

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DEVICE

BiliChek

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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DRS Transcutaneous Bilirubin Reading

Eligibility Criteria

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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
Minimum Eligible Age

24 Hours

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Sartini, DNP

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 16526895 (View on PubMed)

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.

Reference Type RESULT
PMID: 20482289 (View on PubMed)

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.

Reference Type RESULT
PMID: 19021373 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type RESULT
PMID: 19758381 (View on PubMed)

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.

Reference Type RESULT
PMID: 11886508 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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263337

Identifier Type: -

Identifier Source: org_study_id