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Electrocardiography Versus Pulse Oximetry for Newborn Heart Rate Determination

This study is currently recruiting participants.
Verified February 2012 by University of Oklahoma
Sponsor:
Information provided by (Responsible Party):
Douglas Dannaway, MD, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01256346
First received: December 6, 2010
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Prematurity
 Device: Apparatuses

Study Type: Observational
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.


Estimated Enrollment: 30
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)
Groups/Cohorts Assigned Interventions
Babies
Preterm newborn infants thought to be 24-32 weeks gestational age.
 Device: Apparatuses
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.

  Eligibility

Ages Eligible for Study:   up to 20 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Thirty babies believed to be of 24-32 weeks gestational age who are to be born at the University of Oklahoma Health Sciences Center.

Criteria

Inclusion Criteria:

  • Gestational age of 24-32 weeks

Exclusion Criteria:

  • Babies with open abdominal defects
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256346

Locations
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     douglas-dannaway@ouhsc.edu    
Principal Investigator: Douglas C Dannaway, MD            
Sub-Investigator: Anne G Wlodaver, MD            
Sub-Investigator: Marilyn B Escobedo, MD            
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Douglas Dannaway, MD University of Oklahoma
  More Information

Publications:
Petrozzino JJ, Heldt GP, Rich WD, Finer NN. Use of ECG for initial newborn heart rate assessment: a pilot/feasibility study. J Investig Med. 2008;56(1):263-7.

Responsible Party: Douglas Dannaway, MD, Assistant Professor of Pediatrics, University of Oklahoma
ClinicalTrials.gov Identifier: NCT01256346     History of Changes
Other Study ID Numbers: OUHSC IRB 15458
Study First Received: December 6, 2010
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Premature
baby
heart rate
resuscitation

ClinicalTrials.gov processed this record on May 19, 2013