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Evaluation of Pulse Oximetry Sensors in Neonates

NCT00179972 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2015-07-31

No results posted yet for this study

Summary

The purpose of this study is to evaluate sensor longevity and skin integrity with two different models of neonatal pulse oximetry sensors currently used for monitoring oxygen levels in small infants.

Conditions

  • Premature Birth

Interventions

DEVICE

Adhesive and non-adhesive oximetry sensors

A sample of 32 premature infants will be recruited to participate in this study in which an adhesive sensor and a nonadhesive sensor are compared. Both sensors will be simultaneously tested in each subject, for a period of 14 days, with one sensor on the right foot and the other sensor on the left foot. Data will be collected on sensor longevity, skin integrity at the sensor site, reason for sensor replacement and ease of use rating by the clinician. Data will be summarized using descriptive statistics.

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Principal Investigators

  • Barbara A Fleming, RNC, MS · Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility

Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Completion
2010-05-31

Countries

  • United States

Study Locations

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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 NCT00179972 on ClinicalTrials.gov