Comparing pulse rate measurement in newborns using conventional and dry electrode ECG monitors

Conditions: 10028920
neonatal transition
hart rate monitoring
10028971

Registration Number: NL-OMON48339

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Infants born at a gestational age at least 32 weeks who are evaluated on the
resuscitation table during neonatal transition at birth. The estimated birth
weight must be at least 1500 grams

Exclusion Criteria

Infants that have congenital abnormalities of the thorax, an estimated foetal
weight of less than 1500 grams, or are withheld life support at birth

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Correlation of all pulse rate measurements of the Neobeat, ECG monitor and<br /><br>pulse oximetry device:<br /><br>All continuous data will be compared during the first 10 minutes after birth.<br /><br>The relationship between the three devices will be evaluated using Bland-Altman<br /><br>bias analysis; the difference between the measurements will be plotted against<br /><br>their average. The sensitivity, specificity, positive predictive values, and<br /><br>negative predictive values of measurements collected using the Neobeat, ECG and<br /><br>pulse oximetry for detecting HRECG <100 bpm will be calculated.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Correlation between signals of the three monitoring devices over time.<br /><br>All continuous data will be compared during the first 10 minutes after birth.<br /><br>Data will be plotted over time and averaged for 30 second intervals and plotted<br /><br>for each different monitoring device. Data will be compared using an Anova for<br /><br>multiple continuous normally distributed values<br /><br><br /><br>2) Duration from application until a reliable signal is acquired.<br /><br>The time until the first reliable signal is acquired is averaged for all three<br /><br>devices and compared using an ANOVA for normally distributed values. The<br /><br>Friedmans* test will be used for non-normally distributed data. </p><br>