Tissue Oxygen Deprivation as Detected With Raman in Association With Umbilical Artery Catheters
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|ClinicalTrials.gov Identifier: NCT04038203|
Recruitment Status : Not yet recruiting
First Posted : July 30, 2019
Last Update Posted : January 3, 2020
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.
|Condition or disease||Intervention/treatment|
|Tissue Oxygenation||Device: Resonance Raman Spectroscopy (RPS)|
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Resonance Raman Spectroscopy Detects Peripheral Tissue Oxygen Deprivation in Very Low Birth Weight Infants With Umbilical Artery Catheters|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
Neonates with UAC placement
Neonates with birth weight less than 1500 grams with UAC placed on admission. Raman measurements will be obtained simultaneously on the right AND left lower extremity for 15 minutes daily in the first week of life.
Device: Resonance Raman Spectroscopy (RPS)
RRS is a technology that utilizes vibrational spectroscopy, rather than absorbance spectroscopy, to determine the oxyhemoglobin concentration in tissues. Raman measurements for the UAC neonates will be obtained simultaneously on the right AND left lower extremity for 15 minutes daily in the first week of life.
Other Name: Raman
- Number of participants with a Significant Adverse Event (SAEs) [ Time Frame: Week 1 ]SAEs will be a composite of any of the following: lower extremity ischemia, Acute Kidney Injury (AKI), Neo natal Necrotizing Enterocolitis (NEC) or death abstracted from the medical record and/or bedside nurse interview, if necessary.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038203
|Contact: Sonia Aghera, MDfirstname.lastname@example.org|
|Contact: Lauren Ruoss, MDemail@example.com|
|United States, Florida|
|UF Health Children's Hospital|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Lauren Ruoss, MD||University of Florida|