Working… Menu
Trial record 1 of 3 for:    18492509 [PUBMED-IDS]
Previous Study | Return to List | Next Study

Electrocardiography Versus Pulse Oximetry for Newborn Heart Rate Determination

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. 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Recruitment Status : Withdrawn (Study completed by another institution prior to enrollment of first subject.)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
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

Layout table for study information
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
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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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.

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 identifier (NCT number): NCT01256346

Layout table for location information
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Layout table for investigator information
Principal Investigator: Douglas Dannaway, MD University of Oklahoma

Publications of Results:
Layout table for additonal information
Responsible Party: Douglas Dannaway, MD, Assistant Professor of Pediatrics, University of Oklahoma 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:
heart rate
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications