Electrocardiography Versus Pulse Oximetry for Newborn Heart Rate Determination

This study has been withdrawn prior to enrollment.
(Study completed by another institution prior to enrollment of first subject.)
Information provided by (Responsible Party):
Douglas Dannaway, MD, University of Oklahoma
ClinicalTrials.gov Identifier:
First received: December 6, 2010
Last updated: December 1, 2014
Last verified: December 2014
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
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.

Enrollment: 0
Study Start Date: April 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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.

Inclusion Criteria:

  • Gestational age of 24-32 weeks

Exclusion Criteria:

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

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Principal Investigator: Douglas Dannaway, MD University of Oklahoma
  More Information

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: December 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
heart rate

ClinicalTrials.gov processed this record on November 24, 2015