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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This study has been withdrawn prior to enrollment.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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01256346
First Posted: December 8, 2010
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Douglas Dannaway, MD, University of Oklahoma
  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 Douglas Dannaway, MD, University of Oklahoma:

Primary Outcome Measures:
  • Time until accurate heart rate. [ Time Frame: To be determined ]
    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 ]
    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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Minutes   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256346


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

Publications:
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
First Submitted: December 6, 2010
First Posted: December 8, 2010
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Douglas Dannaway, MD, University of Oklahoma:
Premature
baby
heart rate
resuscitation