Validation of Fore-Sight Cerebral & Tissue Oximeter Saturation Measurements on Neonates ≤ 5 kg

Completed

Conditions studied: Bowel Motility

In brief

CASMED, INC. wishes to validate the next generation FORE-SIGHT-II (FS-II) NIRS tissue oximeter monitor for neonatal brain and somatic tissue oxygen saturation (StO2) measurements. This monitor was recently FDA cleared for use on adult subjects.

Key facts

Study ID

NCT02017652

Run by

Sharp HealthCare

People needed

19

Starts

2013-12-01

Expected to finish

2014-12-01

Last updated by the study team

2017-10-09

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Neonatal subjects (32 to 36 and 6/7 weeks), with umbilical venous catheterization will be enrolled from the Neonatal Intensive Care Unit.

You may not qualify if…

• Enrollment in other studies during study period. Inability to tolerate ultrasounds or NIRS sensors

Where it is running

• Sharp Mary Birch Hospital for Women and Newborns — San Diego, California, United States

Full record on ClinicalTrials.gov

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