Characterization of Pre-Term Neonatal Skin
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).
Conditions:
🦠 Skin Disorder
🗓️ Study Start (Actual) 13 October 2023
🗓️ Primary Completion (Estimated) September 2024
✅ Study Completion (Estimated) September 2024
👥 Enrollment (Estimated) 44
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Little Rock, Arkansas, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 24 Hours to 6 Months (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 October 2021
  • First Submitted that Met QC Criteria 8 November 2021
  • First Posted 19 November 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 May 2024
  • Last Update Posted 20 May 2024
  • Last Verified May 2024