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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
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:

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)

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates with birth weight less than 1500 grams, admitted to the University of Florida neonatal intensive care unit (NICU), with UAC placed on admission.
Criteria

Inclusion Criteria:

  • Neonate Inclusion Criteria:

    1. Birth weight less than 1500 grams.
    2. Admitted to the NICU.
    3. UAC placed on admission.
  • Mother Inclusion Criteria:

    1. 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:

    1. Mother is pregnant with fetus with congenital heart defect or major congenital anomaly as described above.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038203


Contacts
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Contact: Sonia Aghera, MD 714-883-3420 sonia.aghera@ufl.edu
Contact: Lauren Ruoss, MD lruoss@ufl.edu

Locations
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United States, Florida
UF Health Children's Hospital
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Lauren Ruoss, MD University of Florida
Publications:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04038203    
Other Study ID Numbers: IRB201900739
OCR25462 ( Other Identifier: UF OnCore )
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
neonates
low birth weight
spectroscopy
Umbilical Artery Catheter (UAC)
Additional relevant MeSH terms:
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Birth Weight
Body Weight
Signs and Symptoms