MedTrace Logo

A Pilot Study- Monitoring Cerebral Blood Flow in Neonates With Congenital Heart Defects

NCT03512613 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2018-06-04

No results posted yet for this study

Summary

Congenital heart defects have an incidence of 9/1000 live births. Infants with congenital heart defects such as Transposition of Great Arteries / Hypoplastic Left Heart are at risk for brain injury because of concomitant brain malformations. Previous studies of cerebral MRI in infants with congenital heart defects showed that in 20-40% of cases there was preoperative brain injury and post operative with the same incidence. These findings are strongly associated with early and long-term neurodevelopmental injury.

There is a necessity for a non invasive device who will monitor the cerebral blood flow during the hospitalization prior and post the cardiac defect repair surgery.

The previous modal of the study device has been cleared for marketing by the FDA (k150268).

The main goal of this study is to demonstrate that the new design of Ornim's c-FLOW 3310-P is easy to operate and effective in monitoring changes in cerebral blood flow in neonates as demonstrated in adults.

Conditions

  • Congenital Heart Defect
  • Cerebrovascular Circulation

Interventions

DEVICE

c-FLOW 3310-P

c-FLOW 3310-P is a continuous, non-invasive monitor of cerebral deep tissue blood flow used to measure relative changes in blood flow. The device monitors regional micro circulatory blood flow in tissues, by using sensors placed near the area of interest.

Sponsors & Collaborators

  • Ornim Medical

    lead INDUSTRY

Principal Investigators

  • Omer Bar Yosef, MD · Sheba Medical Center

Eligibility

Max Age
4 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2019-05-31
Completion
2019-05-31

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03512613 on ClinicalTrials.gov