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.
1. Validate FS-II abdominal StO2 measurements from the intestines, liver, and flank to
umbilical venous and arterial blood oxygen saturation.
2. Validate FS-II cerebral StO2 measurements against the predicate FDA cleared FORE-SIGHT-I
3. Collect data from FS-II sensors on the forehead and abdomen (intestine) for 24 hours to
compare dynamic changes vs the pulse oximeter. For larger neonates, add a predicate FS-I
sensor to the opposite side forehead for dynamic comparison to FS-II measurements.
4. Obtain abdominal Near Infrared Spectroscopy (NIRS) data simultaneous with accepted
measures of bowel motility (a. frequency and composition of stools, and b. Ultrasound
assessment for the frequency and magnitude of bowel peristalsis, if available).
Neonatal subjects (32 to 36 and 6/7 weeks), with umbilical venous catheterization will be
enrolled from the Neonatal Intensive Care Unit.
Enrollment in other studies during study period. Inability to tolerate ultrasounds or NIRS