Electrocardiography Versus Pulse Oximetry for Newborn Heart Rate Determination

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01256346

Enrollment

Registered

2010-12-08

Start date

2011-04-30

Completion date

2011-04-30

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity

Keywords

Premature, baby, heart rate, resuscitation

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.

Interventions

DEVICEApparatuses

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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 20 Minutes

Healthy volunteers

Inclusion criteria

* Gestational age of 24-32 weeks

Exclusion criteria

* Babies with open abdominal defects

Design outcomes

Primary

Measure	Time frame	Description
Time until accurate heart rate.	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

Measure	Time frame	Description
Intermeasurement accuracy	To be determined	Assessment of the level of accuracy between the two times to be measured.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026