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Electrocardiography Versus Pulse Oximetry for Newborn Heart Rate Determination

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ClinicalTrials.gov Identifier: NCT01256346
Recruitment Status : Withdrawn (Study completed by another institution prior to enrollment of first subject.)
First Posted : December 8, 2010
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Douglas Dannaway, MD, University of Oklahoma

Brief Summary:
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 or disease Intervention/treatment
Prematurity Device: Apparatuses

Study Type : Observational
Actual Enrollment : 0 participants
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.
Study Start Date : April 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 :
  1. Intermeasurement accuracy [ Time Frame: To be determined ]
    Assessment of the level of accuracy between the two times to be measured.



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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

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

Publications of Results:
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 Posted: December 8, 2010    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

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