The Effects of a New Wireless Non-Adhesive Cardiorespiratory Monitoring Device on the Skin Conditions of Preterm Infants.

AIM: The aim of our study was to investigate skin conditions when wearing and removing a novel wireless non-adhesive cardiorespiratory monitoring device for neonates (Bambi-Belt) compared to standard adhesive electrodes. STUDY DESIGN: This was a prospective study including preterm neonates requiring cardiorespiratory monitoring. Besides standard electrodes, the infants wore a Bambi Belt for 10 consecutive days. Their skin conditions were assessed using Trans Epidermal Water Loss (TEWL) and the Neonatal Skin Condition Score (NSCS) after daily belt and standard electrode removal. The ∆TEWL was calculated as the difference between the TEWL at the device's location (Bambi-Belt/standard electrode) and the adjacent control skin location, with a higher ∆TEWL indicating skin damage. RESULTS: A total of 15 infants (gestational age (GA): 24.1-35.6 wk) were analyzed. The ΔTEWL significantly increased directly after electrode removal (10.95 ± 9.98 g/m2/h) compared to belt removal (5.18 ± 6.71 g/m2/h; F: 8.73, p = 0.004) and after the washout period (3.72 ± 5.46 g/m2/h vs. 1.86 ± 3.35 g/m2/h; F: 2.84, p = 0.09), although the latter did not reach statistical significance. The TEWL was not influenced by prolonged belt wearing. No significant differences in the NSCS score were found between the belt and electrode (OR: 0.69, 95% CI [0.17, 2.88], p = 0.6). CONCLUSION: A new wireless non-adhesive device for neonatal cardiorespiratory monitoring was well tolerated in preterm infants and may be less damaging during prolonged wearing.

Cardiorespiratory monitoring with a wireless and nonadhesive belt measuring diaphragm activity in preterm and term infants: A multicenter non-inferiority study.

INTRODUCTION: We determined if the heart rate (HR) monitoring performance of a wireless and nonadhesive belt is non-inferior compared to standard electrocardiography (ECG). Secondary objective was to explore the belt's respiratory rate (RR) monitoring performance compared to chest impedance (CI). METHOD: In this multicenter non-inferiority trial, preterm and term infants were simultaneously monitored with the belt and conventional ECG/CI for 24 h. HR monitoring performance was estimated with the HR difference and ability to detect cardiac events compared to the ECG, and the incidence of HR-data loss per second. These estimations were statistically compared to prespecified margins to confirm equivalence/non-inferiority. Exploratory RR analyses estimated the RR trend difference and ability to detect apnea/tachypnea compared to CI, and the incidence of RR-data loss per second. RESULTS: Thirty-nine infants were included. HR monitoring with the belt was non-inferior to the ECG with a mean HR difference of 0.03 beats per minute (bpm) (standard error [SE] = 0.02) (95% limits of agreement [LoA]: [-5 to 5] bpm) (p < 0.001). Second, sensitivity and positive predictive value (PPV) for cardiac event detection were 94.0% (SE = 0.5%) and 92.6% (SE = 0.6%), respectively (p ≤ 0.001). Third, the incidence of HR-data loss was 2.1% (SE = 0.4%) per second (p < 0.05). The exploratory analyses of RR showed moderate trend agreement with a mean RR-difference of 3.7 breaths/min (SE = 0.8) (LoA: [-12 to 19] breaths/min), but low sensitivities and PPV's for apnea/tachypnea detection. The incidence of RR-data loss was 2.2% (SE = 0.4%) per second. CONCLUSION: The nonadhesive, wireless belt showed non-inferior HR monitoring and a moderate agreement in RR trend compared to ECG/CI. Future research on apnea/tachypnea detection is required.

Rapid exome sequencing as a first-tier test in neonates with suspected genetic disorder: results of a prospective multicenter clinical utility study in the Netherlands.

The introduction of rapid exome sequencing (rES) for critically ill neonates admitted to the neonatal intensive care unit has made it possible to impact clinical decision-making. Unbiased prospective studies to quantify the impact of rES over routine genetic testing are, however, scarce. We performed a clinical utility study to compare rES to conventional genetic diagnostic workup for critically ill neonates with suspected genetic disorders. In a multicenter prospective parallel cohort study involving five Dutch NICUs, we performed rES in parallel to routine genetic testing for 60 neonates with a suspected genetic disorder and monitored diagnostic yield and the time to diagnosis. To assess the economic impact of rES, healthcare resource use was collected for all neonates. rES detected more conclusive genetic diagnoses than routine genetic testing (20% vs. 10%, respectively), in a significantly shorter time to diagnosis (15 days (95% CI 10-20) vs. 59 days (95% CI 23-98, p < 0.001)). Moreover, rES reduced genetic diagnostic costs by 1.5% (€85 per neonate). CONCLUSION:  Our findings demonstrate the clinical utility of rES for critically ill neonates based on increased diagnostic yield, shorter time to diagnosis, and net healthcare savings. Our observations warrant the widespread implementation of rES as first-tier genetic test in critically ill neonates with disorders of suspected genetic origin. WHAT IS KNOWN: • Rapid exome sequencing (rES) enables diagnosing rare genetic disorders in a fast and reliable manner, but retrospective studies with neonates admitted to the neonatal intensive care unit (NICU) indicated that genetic disorders are likely underdiagnosed as rES is not routinely used. • Scenario modeling for implementation of rES for neonates with presumed genetic disorders indicated an expected increase in costs associated with genetic testing. WHAT IS NEW: • This unique prospective national clinical utility study of rES in a NICU setting shows that rES obtained more and faster diagnoses than conventional genetic tests. • Implementation of rES as replacement for all other genetic tests does not increase healthcare costs but in fact leads to a reduction in healthcare costs.

Multicentre paired non-inferiority study of the cardiorespiratory monitoring performance of the wireless and non-adhesive Bambi® belt measuring diaphragm activity in neonates: study protocol.

INTRODUCTION: Cardiorespiratory monitoring is used in the neonatal intensive care unit (NICU) to assess the clinical status of newborn infants and detect critical deteriorations in cardiorespiratory function. Currently, heart rate (HR) is monitored by electrocardiography (ECG) and respiration by chest impedance (CI). Disadvantages of current monitoring techniques are usage of wired adhesive electrodes which may damage the skin and hinder care. The Bambi® belt is a wireless and non-adhesive alternative that enables cardiorespiratory monitoring by measuring electrical activity of the diaphragm via transcutaneous electromyography. A previous study showed feasibility of the Bambi® belt and this study compares the belt performance to ECG and CI. METHODS AND ANALYSIS: This multicentre non-inferiority paired study will be performed in the NICU of the Máxima Medical Center (MMC) in Veldhoven and the Emma Children's Hospital, Amsterdam University Medical Centre (AmsterdamUMC) in Amsterdam, The Netherlands. 39 infants in different postmenstrual age groups (minimally 10 infants<30 weeks, between 30-32 weeks and >32 weeks) will be recruited. These infants will be monitored with the Bambi® belt in addition to standard ECG and CI for 24 hours. The primary outcome is the HR, studied with three criteria: (1) the limits of agreement of the HR measurements in terms of the second-to-second difference in the HR between the belt and standard ECG, (2) the detection of cardiac events consisting of bradycardia and tachycardia and (3) the quality of HR-monitoring. The secondary outcome is the respiratory rate (RR), studied with the criteria (1) agreement in RR-trend monitoring, (2) apnoea and tachypnoea detection and (3) reliable registrations. ETHICS AND DISSEMINATION: This protocol was approved by the Medical Ethical Committee of the MMC and the Central Committee for Human Research. The MMC started patient recruitment in July and the AmsterdamUMC in August 2021. The results will be presented at conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NL9480.