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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: Completed NA study, sponsored by University of Arkansas.
NCT05127044 is a NA study that has completed, run by University of Arkansas. The registered enrollment target is 44 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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.
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 |
What the finished NCT05127044 record still lists
NCT05127044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Diffuse Reflectance Spectroscopy is the first listed.
NCT05127044 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05127044's enrollment target sits among peer trials
44 1423rd of 2000 higher than 566 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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