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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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 (FS-I) monitor.
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).

Conditions

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Bowel Motility

Keywords

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bowel motility cerebral perfusion intestinal perfusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm Infants

Preterm infants 32 to 36 weeks will be eligible for this study

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Anup Katheria, M.D.

Director of Neonatal Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anuup Katheria, MD

Role: PRINCIPAL_INVESTIGATOR

Sharp Mary Birch Hospital for Women & Newborns

Locations

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Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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FORE-SIGHT

Identifier Type: -

Identifier Source: org_study_id