Impact of immediate and continuous heart rate feedback by dry electrode ECG on time to initiation of ventilation after birth: protocol for a randomised controlled trial

Siren Rettedal, Amalie Kibsgaard, Joar Eilevstjønn, Jan Terje Kvaløy, Peder Aleksander Bjorland, Hanne Markhus Pike, Joanna Haynes, Thomas Bailey Tysland, Ketil Størdal, Kari Holte, Peter G Davis, Hege Langli Ersdal
2022 BMJ Open  
Introduction3%–8% of newborns need positive pressure ventilation (PPV) after birth. Heart rate (HR) is considered the most sensitive indicator of the newborns' condition and response to resuscitative interventions. According to guidelines, HR should be assessed and PPV initiated within 60 s after birth in non-breathing newborns. Dry electrode ECG can provide accurate feedback on HR immediately after birth and continuously during resuscitation. The impact of early and continuous HR feedback is
more » ... known.Method and analysisThis single-centre randomised controlled trial seeks to determine if HR feedback by dry electrode ECG immediately after birth and continuously during newborn resuscitation results in more timely initiation of PPV, improved ventilation and short-term outcomes compared with standard HR assessment.In all newborns≥34 gestational weeks, the dry electrode ECG sensor is placed on the upper abdomen immediately after birth as an additional modality of HR assessment. The device records and stores HR signals. In intervention subjects, the HR display is visible to guide decision-making and further management, in control subjects the display is masked. Standard HR assessment is by stethoscope, gel-electrode ECG and/or pulse oximetry (PO).Time of birth is registered in the Liveborn app. Time of initiation and duration of PPV is calculated from video recordings. Ventilation parameters are retrieved from the ventilation monitor, oxygen saturation and HR from the PO and gel-electrode ECG monitors.The primary endpoint is proportion of resuscitated newborns who receive PPV within 60 s after birth. To detect a 50% increase with power of 90% using an overall significance level of 0.05 and 1 interim analysis, 169 newborns are needed in each group.Ethics and disseminationApproval by the Norwegian National Research Ethics Committee West (2018/338). Parental consent is sought at routine screening early in pregnancy. The results will be published in peer-reviewed journal and presented at conferences.Trial registration numberNCT03849781.
doi:10.1136/bmjopen-2022-061839 pmid:36691167 pmcid:PMC9454047 fatcat:uvpgfa25zja75jlhn4imind4qy