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NCT01256346 Clinical Trial

Electrocardiography Versus Pulse Oximetry for Newborn Heart Rate Determination

Prematurity Clinical Trial

Official title:
A Comparison of Electrocardiography Versus Pulse Oximetry for Determination of Initial Heart Rate in Preterm Newborns: A Pilot Study.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01256346
Other study ID # OUHSC IRB 15458
Secondary ID
Status Withdrawn
Phase N/A
First received December 6, 2010
Last updated December 1, 2014
Start date April 2011
Est. completion date April 2011

Study information
Verified date December 2014
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 20 Minutes
Eligibility Inclusion Criteria:

- Gestational age of 24-32 weeks

Exclusion Criteria:

- Babies with open abdominal defects

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (6)

Kamlin CO, Dawson JA, O'Donnell CP, Morley CJ, Donath SM, Sekhon J, Davis PG. Accuracy of pulse oximetry measurement of heart rate of newborn infants in the delivery room. J Pediatr. 2008 Jun;152(6):756-60. doi: 10.1016/j.jpeds.2008.01.002. Epub 2008 Mar — View Citation

Kamlin CO, O'Donnell CP, Everest NJ, Davis PG, Morley CJ. Accuracy of clinical assessment of infant heart rate in the delivery room. Resuscitation. 2006 Dec;71(3):319-21. Epub 2006 Sep 20. — View Citation

O'Donnell CP, Kamlin CO, Davis PG, Morley CJ. Feasibility of and delay in obtaining pulse oximetry during neonatal resuscitation. J Pediatr. 2005 Nov;147(5):698-9. — View Citation

Owen CJ, Wyllie JP. Determination of heart rate in the baby at birth. Resuscitation. 2004 Feb;60(2):213-7. — View Citation

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.

Vento M, Aguar M, Leone TA, Finer NN, Gimeno A, Rich W, Saenz P, Escrig R, Brugada M. Using intensive care technology in the delivery room: a new concept for the resuscitation of extremely preterm neonates. Pediatrics. 2008 Nov;122(5):1113-6. doi: 10.1542 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Time until accurate heart rate. The elapsed time (in seconds) between application of the specific measuring apparatus (pulse oximeter probe or electrocardiograph leads) and measurement of heart rate. To be determined No
Secondary Intermeasurement accuracy Assessment of the level of accuracy between the two times to be measured. To be determined No
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