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

Withdrawn

• Conditions: Tissue Oxygenation
• Interventions: Device: Resonance Raman Spectroscopy (RPS)

• Registration Number: NCT04038203
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-30
• Study Start: 2023-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neonates with UAC placement	Resonance Raman Spectroscopy (RPS)	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with a Significant Adverse Event (SAEs)	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.

Trial Locations

Locations (1)

UF Health Children's Hospital; 🇺🇸 Gainesville, Florida, United States