Status:

COMPLETED

Verification of Pulse Oximetry in Neonatal Population

Lead Sponsor:

Children's Hospitals and Clinics of Minnesota

Conditions:

Respiratory Distress Syndrome

Eligibility:

All Genders

1-30 years

Brief 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 w...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2009

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT00751439

Start Date

June 1 2008

End Date

September 1 2009

Last Update

June 11 2010

Active Locations (1)

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Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, United States, 55404