Aim To determine whether the IntelliVue monitor (ECG plus Masimo pulse oximeter (PO)) displays heart rate (HR) at birth more quickly than Nellcor PO (PO alone) among infants of 29–35 weeks’ gestational age.
Methods Unmasked parallel group randomised (1:1) study.
Results We planned to enrol 100 infants; however, the study was terminated due to the COVID-19 pandemic when 39 infants had been enrolled (17 randomised to IntelliVue, 22 to Nellcor). We found no differences between the groups in the time to first HR display (median (IQR) IntelliVue ECG 49 (33, 71) vs Nellcor 47 (37, 86) s, p>0.999), in the proportion who had a face mask applied for breathing support, or in the time at which it was applied. Infants monitored with IntelliVue were handled more frequently and for longer.
Conclusion IntelliVue ECG did not display HR more quickly than Nellcor PO in preterm infants. We found no differences in the rate of or time to intervention between groups. Our study was terminated early so these findings should be interpreted with caution.
Trial registration number ISRCTN16473881
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Twitter @mcrmurphy, @Lisa
Contributors MCM participated in study concept, study design, data collection, data analysis and writing of the first draft of the manuscript. AJ and JC participated in data collection. LKMcC participated in data analysis and review of the manuscript prior to submission. CPFOD participated in study concept, study design, data analysis and writing of the manuscript.
Funding MCM is supported by a Clinical Research Fellowship from National Children’s Research Centre, Children’s Health Ireland, Crumlin, Dublin, Ireland (R17637).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The study protocol was approved by our Research Ethics Committee and registered before the first patient was enrolled (ISRCTN16473881).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.
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