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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tissue Oxygenation

Intervention / Treatment
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* Device: Resonance Raman Spectroscopy (RPS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonate Inclusion Criteria: Birth weight less than 1500 grams. Admitted to the NICU. UAC placed on admission. Mother Inclusion Criteria: Admitted to the labor and delivery or antenatal floors with reasonable chance of delivery of a neonate weighing less than 1500 grams as determined by the obstetrics team. Exclusion Criteria: Neonate Exclusion Criteria: 1. Neonates with congenital heart defects or major congenital anomalies such as known or suspected inborn errors of metabolism, ambiguous genitalia, neural tube defects, malignancy, abdominal wall defects, airway defects and chromosomal anomalies. Mother Exclusion Criteria: Mother is pregnant with fetus with congenital heart defect or major congenital anomaly as described above.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonates with UAC placement<br>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)<br>* 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.<br>* Other names: Raman;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a Significant Adverse Event (SAEs) | 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. | Week 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonates, low birth weight, spectroscopy, Umbilical Artery Catheter (UAC)