Verification of Pulse Oximetry in Neonatal Population

This study is currently recruiting participants.

Verified by Children's Hospitals and Clinics of Minnesota, September 2008

First Received: September 11, 2008 Last Updated: September 22, 2008 History of Changes

Sponsored by:	Children's Hospitals and Clinics of Minnesota
Information provided by:	Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:	NCT00751439

Purpose

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.

Condition
Respiratory Distress Syndrome

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Verification of Pulse Oximetry in Neonatal Population

Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	25
Study Start Date:	June 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	up to 30 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Neonates 25 weeks gestation to full term

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751439

Contacts

Contact: Mark C Mammel, M.D.

651-220-6261

mamme001@tc.umn.edu

Locations

United States, Minnesota
Children's Hospitals and Clinics of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55404
Principal Investigator: Mark Mammel, MD

Sponsors and Collaborators

Children's Hospitals and Clinics of Minnesota

Investigators

Principal Investigator:

Mark C Mammel, M.D.

Children's Hospitals & Clinics of Minnesota

More Information

No publications provided

Responsible Party:	Children's Hospitals & Clinics of Minnesota ( Mark Mammel, M.D. )
Study ID Numbers:	0802-024
Study First Received:	September 11, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00751439 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospitals and Clinics of Minnesota:

Oximeter
Arterial blood gas
comparison

Study placed in the following topic categories:

Respiratory Tract Diseases
Lung Diseases
Respiration Disorders

Respiratory Distress Syndrome, Adult
Acute Respiratory Distress Syndrome
Flatulence

Additional relevant MeSH terms:

Pathologic Processes
Disease
Respiratory Tract Diseases
Lung Diseases

Syndrome
Respiration Disorders
Respiratory Distress Syndrome, Adult

ClinicalTrials.gov processed this record on May 07, 2009