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NCT05127044 · ClinicalTrials.gov registry record · NA
Characterization of Pre-Term Neonatal Skin
A NA study, sponsored by University of Arkansas.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT05127044 is a NA study that has completed, run by University of Arkansas. The registered enrollment target is 44 participants.
The verdict
NCT05127044, a NA study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study 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).
Interventions
- DEVICE Diffuse Reflectance Spectroscopy
- DIAGNOSTIC_TEST BiliChek
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2023-10-13 |
| Est. Completion | 2024-08-17 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05127044
The ClinicalTrials.gov registry entry for NCT05127044 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Diffuse Reflectance Spectroscopy is the first listed.
NCT05127044 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05127044 about?
NCT05127044 is a clinical study titled "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 evalu...
What is the current status of trial NCT05127044?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2023-10-13. Estimated completion is 2024-08-17.
What interventions are being tested in trial NCT05127044?
The interventions under investigation include: Diffuse Reflectance Spectroscopy (DEVICE), BiliChek (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05127044?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
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