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Withdrawn No phase listed Observational

Tissue Oxygen Deprivation as Detected With Raman in Association With Umbilical Artery Catheters

ClinicalTrials.gov ID: NCT04038203

Public ClinicalTrials.gov record NCT04038203. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 10, 2026, 8:24 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Resonance Raman Spectroscopy Detects Peripheral Tissue Oxygen Deprivation in Very Low Birth Weight Infants With Umbilical Artery Catheters

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Umbilical artery catheters (UACs) are associated with significant morbidity in preterm neonates however are necessary for the management of this high risk population. UACs have been linked to serious adverse events (SAEs) including arterial thrombosis, necrotizing enterocolitis, limb ischemia, and renal failure. Resonance Raman Spectroscopy (RRS), raman for short, is a technology that utilizes vibrational spectroscopy, rather than absorbance spectroscopy, to determine the oxyhemoglobin concentration in tissues. In this prospective, observational study, daily measurements of StO2 of low birth weight neonates using raman spectroscopy will be correlated with UACs.The study team hypothesizes that raman can detect changes in peripheral tissue oxygenation in the ipsilateral extremity to the UAC and that raman is more sensitive at detecting changes in peripheral tissue oxygenation then common metrics used to monitor neonatal hemodynamics. If successful, this study would demonstrate that raman can be used as an early marker of tissue oxygen deprivation in neonates with UACs and maybe used to guide management in other clinical scenarios where StO2 is affected.

Study identification

NCT ID
NCT04038203
Recruitment status
Withdrawn
Study type
Observational
Phase
Not listed
Lead sponsor
University of Florida
Other
Enrollment
Not listed

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2023
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024
Last update posted
Jan 11, 2024

2023 – 2024

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
UF Health Children's Hospital Gainesville Florida 32608

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04038203, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 11, 2024 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04038203 live on ClinicalTrials.gov.

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