Electrocardiography Versus Pulse Oximetry for Newborn Heart Rate Determination
This study is currently recruiting participants.
Verified February 2012 by University of Oklahoma
University of Oklahoma
Information provided by (Responsible Party):
Douglas Dannaway, MD, University of Oklahoma
First received: December 6, 2010
Last updated: February 21, 2012
Last verified: February 2012
The goal of this study is to compare the time required for accurate heart rate measurement of the preterm newborn when using pulse oximetry versus electrocardiography leads.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Comparison of Electrocardiography Versus Pulse Oximetry for Determination of Initial Heart Rate in Preterm Newborns: A Pilot Study.|
Further study details as provided by University of Oklahoma:
Primary Outcome Measures:
- Time until accurate heart rate. [ Time Frame: To be determined ] [ Designated as safety issue: No ]The elapsed time (in seconds) between application of the specific measuring apparatus (pulse oximeter probe or electrocardiograph leads) and measurement of heart rate.
Secondary Outcome Measures:
- Intermeasurement accuracy [ Time Frame: To be determined ] [ Designated as safety issue: No ]Assessment of the level of accuracy between the two times to be measured.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||April 2012|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Preterm newborn infants thought to be 24-32 weeks gestational age.
Each baby will have both pulse oximetry leads (Massimo Radical 7) and electrocardiography leads (3M™ Red Dot™ Neonatal Limb Band Monitoring Electrodes, Pre-wired) applied. The time required for each modality to register a heart rate will be compared.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256346
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Douglas C Dannaway, MD 405-271-5215 ext 42048 firstname.lastname@example.org|
|Principal Investigator: Douglas C Dannaway, MD|
|Sub-Investigator: Anne G Wlodaver, MD|
|Sub-Investigator: Marilyn B Escobedo, MD|
Sponsors and Collaborators
University of Oklahoma
|Principal Investigator:||Douglas Dannaway, MD||University of Oklahoma|