The Impact of Continuous Transcutaneous CO2 (TCCO2) Monitoring in Extremely Low Birth Weight (ELBW) Infants

Overview

An observational study comparing outcomes of Extremely Low Birth Weight (ELBW) infants that were monitored with non-invasive Transcutaneous CO2 (TCCO2) monitor to infants that were not monitored by TCCO2 monitor.

Full Title of Study: “The Impact of Continuous Transcutaneous CO2 Monitoring (TCCO2) in Extremely Low Birth Weight (ELBW) Infants: A Prospective Observational, Multi-Center Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 1, 2022

Arms, Groups and Cohorts

  • Study group
    • TCCO2 monitoring
  • Control group
    • Routine monitoring

Clinical Trial Outcome Measures

Primary Measures

  • IVH-Intraventricular Hemorrhage
    • Time Frame: Repeated scans until infant reaches corrected age of 42 weeks
    • Intraventricular Hemorrhage
  • PVL- Periventricular Leukomalacia
    • Time Frame: Repeated scans until infant reaches corrected age of 42 weeks
    • Periventricular Leukomalacia

Participating in This Clinical Trial

Inclusion Criteria

  • ELBW infants Need of respiratory support Exclusion Criteria:

  • Parental refusal IVH before study entry chromosomal abnormalities congenital central nervous system (CNS) abnormalities

Gender Eligibility: All

Minimum Age: 0 Minutes

Maximum Age: 24 Hours

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rambam Health Care Campus
  • Provider of Information About this Clinical Study
    • Principal Investigator: Liron Borenstein MD, Liron Borenstein Levin,MD, Neonatologist – Rambam Health Care Campus

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