Clinical trial NCT04038203: Tissue Oxygen Deprivation as Detected With Raman in Association With Umbilical Artery Catheters
Official title: Resonance Raman Spectroscopy Detects Peripheral Tissue Oxygen Deprivation in Very Low Birth Weight Infants With Umbilical Artery Catheters
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Tissue Oxygenation
Keywords: neonates
low birth weight
spectroscopy
Umbilical Artery Catheter (UAC)
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Number of participants with a Significant Adverse Event (SAEs)
timeFrame: Week 1
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Children's Hospital
state: Florida
Study officials:
affiliation: University of Florida
name: Lauren Ruoss, MD
role: PRINCIPAL_INVESTIGATOR
References:
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