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

University of Florida

Status: Withdrawn

Conditions: Tissue Oxygenation

Treatments: Device: Resonance Raman Spectroscopy (RPS)

Study type: Observational

Funder types: Other

Identifiers

NCT04038203

OCR25462 (Other Identifier)

IRB201900739

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Neonates with UAC placement

Description:

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.

Treatment:

Device: Resonance Raman Spectroscopy (RPS)