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NCT00751439 Clinical Trial

Verification of Pulse Oximetry in Neonatal Population

Respiratory Distress Syndrome Clinical Trial

Official title:
Verification of Pulse Oximetry in Neonatal Population

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00751439
Other study ID # 0802-024
Secondary ID
Status Completed
Phase N/A
First received September 11, 2008
Last updated June 10, 2010
Start date June 2008
Est. completion date September 2009

Study information
Verified date June 2010
Source Children's Hospitals and Clinics of Minnesota
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this his post-market, observational study titled Verification of Pulse Oximetry in the Neonatal Population is to gather data to further support the accuracy of Nonin's pulse oximeters when used in the neonate population. Neonates who are currently undergoing arterial blood gas (ABG) sampling, as part of their medical care will be recruited to participate in this study for collecting opportunity samples. Nonin's PureLight® noninvasive sensor will be applied to a foot of the neonate; an adhesive wrap secures the sensor to the neonate. The sensor immediately begins obtaining SpO2 and pulse rate measurements which are sent to the oximeter module for display on the Electronic Data Collection System (EDCS). At the time the prescribed ABG is drawn, the EDCS must have a marker captured to identify the end of the ABG for SpO2 comparison. The SpO2 accuracy of pulse oximeter will be measured by comparing SpO2 readings of the pulse oximeter to values of SaO2 (opportunity samples) determined by a CO-oximeter.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date September 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group N/A to 30 Days
Eligibility Inclusion Criteria:

- Gestational age: 25 weeks to full term

- Weight range: No minimum or maximum range

- Age: up to 1 month (30 DAYS)

- Gender: Both

- ABGs as part of their medical care, to be analyzed by co-oximeter

- Consent signed by at least one legal guardian

Exclusion Criteria:

- Presence of any skin irritation or breakdown on the foot

- Foot impediments which would preclude proper placement of the sensor

- Clinical condition precluding the use of adhesive materials

- Cessation of ABGs during study enrollment

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospitals and Clinics of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

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