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      Evaluating a Novel Infant Heart Rate Detector for Neonatal Resuscitation Efforts: Protocol for a Proof-of-Concept Study

      research-article
      , BEng 1 , , , PhD 1 , , MD 2
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      newborn, electrocardiogram, ECG, dry electrode, heart rate, pediatric, resuscitation, infant, vital signs, neonatal

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          Abstract

          Background

          Over 10 million newborns worldwide undergo resuscitation at birth each year. Pediatricians may use electrocardiogram (ECG), pulse oximetry (PO), and stethoscope in determining heart rate (HR), as HR guides the need for and steps of resuscitation. HR must be obtained quickly and accurately. Unfortunately, the current diagnostic modalities are either too slow, obtaining HR in more than a minute, or inaccurate. With time constraints, a reliable robust heart rate detector (HRD) modality is required. This paper discusses a protocol for conducting a methods-based comparison study to determine the HR accuracy of a novel real-time HRD based on 3D-printed dry-electrode single-lead ECG signals for cost-effective and quick HR determination. The HRD’s HR results are compared to either clinical-grade ECG or PO monitors to ensure robustness and accuracy.

          Objective

          The purpose of this study is to design and examine the feasibility of a proof-of-concept HRD that quickly obtains HR using biocompatible 3D-printed dry electrodes for single-lead neonatal ECG acquisition. This study uses a novel HRD and compares it to the gold-standard 3-lead clinical ECG or PO in a hospital setting.

          Methods

          A cross-sectional study is planned to be conducted in the neonatal intensive care unit or postpartum unit of a large community teaching hospital in Toronto, Canada, from June 2023 to June 2024. In total, 50 newborns will be recruited for this study. The HRD and an ECG or PO monitor will be video recorded using a digital camera concurrently for 3 minutes for each newborn. Hardware-based signal processing and patent-pending embedded algorithm-based HR estimation techniques are applied directly to the raw collected single-lead ECG and displayed on the HRD in real time during video recordings. These data will be annotated and compared to the ECG or PO readings at the same points in time. Accuracy, F 1-score, and other statistical metrics will be produced to determine the HRD’s feasibility in providing reliable HR.

          Results

          The study is ongoing. The projected end date for data collection is around July 2024.

          Conclusions

          The study will compare the novel patent-pending 3D-printed dry electrode–based HRD’s real-time HR estimation techniques with the state-of-the-art clinical-grade ECG or PO monitors for HR accuracy and examines how fast the HRD provides reliable HR. The study will further provide recommendations and important improvements that can be made to implement the HRD for clinical applications, especially in neonatal resuscitation efforts. This work can be seen as a stepping stone in the development of robust dry-electrode single-lead ECG devices for HR estimations in the pediatric population.

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/45512

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          Most cited references19

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          Neonatal resuscitation and immediate newborn assessment and stimulation for the prevention of neonatal deaths: a systematic review, meta-analysis and Delphi estimation of mortality effect

          Background Of 136 million babies born annually, around 10 million require assistance to breathe. Each year 814,000 neonatal deaths result from intrapartum-related events in term babies (previously “birth asphyxia”) and 1.03 million from complications of prematurity. No systematic assessment of mortality reduction from tactile stimulation or resuscitation has been published. Objective To estimate the mortality effect of immediate newborn assessment and stimulation, and basic resuscitation on neonatal deaths due to term intrapartum-related events or preterm birth, for facility and home births. Methods We conducted systematic reviews for studies reporting relevant mortality or morbidity outcomes. Evidence was assessed using GRADE criteria adapted to provide a systematic approach to mortality effect estimates for the Lives Saved Tool (LiST). Meta-analysis was performed if appropriate. For interventions with low quality evidence but strong recommendation for implementation, a Delphi panel was convened to estimate effect size. Results We identified 24 studies of neonatal resuscitation reporting mortality outcomes (20 observational, 2 quasi-experimental, 2 cluster randomized controlled trials), but none of immediate newborn assessment and stimulation alone. A meta-analysis of three facility-based studies examined the effect of resuscitation training on intrapartum-related neonatal deaths (RR= 0.70, 95%CI 0.59-0.84); this estimate was used for the effect of facility-based basic neonatal resuscitation (additional to stimulation). The evidence for preterm mortality effect was low quality and thus expert opinion was sought. In community-based studies, resuscitation training was part of packages with multiple concurrent interventions, and/or studies did not distinguish term intrapartum-related from preterm deaths, hence no meta-analysis was conducted. Our Delphi panel of 18 experts estimated that immediate newborn assessment and stimulation would reduce both intrapartum-related and preterm deaths by 10%, facility-based resuscitation would prevent a further 10% of preterm deaths, and community-based resuscitation would prevent further 20% of intrapartum-related and 5% of preterm deaths. Conclusion Neonatal resuscitation training in facilities reduces term intrapartum-related deaths by 30%. Yet, coverage of this intervention remains low in countries where most neonatal deaths occur and is a missed opportunity to save lives. Expert opinion supports smaller effects of neonatal resuscitation on preterm mortality in facilities and of basic resuscitation and newborn assessment and stimulation at community level. Further evaluation is required for impact, cost and implementation strategies in various contexts. Funding This work was supported by the Bill & Melinda Gates Foundation through a grant to the US Fund for UNICEF, and to the Saving Newborn Lives program of Save the Children, through Save the Children US.
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            Early initiation of basic resuscitation interventions including face mask ventilation may reduce birth asphyxia related mortality in low-income countries: a prospective descriptive observational study.

            Early initiation of basic resuscitation interventions within 60 s in apneic newborn infants is thought to be essential in preventing progression to circulatory collapse based on experimental cardio-respiratory responses to asphyxia. The objectives were to describe normal transitional respiratory adaption at birth and to assess the importance of initiating basic resuscitation within the first minutes after birth as it relates to neonatal outcome. This is an observational study of neonatal respiratory adaptation at birth in a rural hospital in Tanzania. Research assistants (n=14) monitored every newborn infant delivery and the response of birth attendants to a depressed baby. Time to initiation of spontaneous respirations or time to onset of breathing following stimulation/suctioning, or face mask ventilation (FMV) in apneic infants, and duration of FMV were recorded. 5845 infants were born; 5689 were liveborn, among these 4769(84%) initiated spontaneous respirations; 93% in ≤30 s and 99% in ≤60 s. Basic resuscitation (stimulation, suction, and/or FMV) was attempted in 920/5689(16.0%); of these 459(49.9%) received FMV. Outcomes included normal n=5613(96.0%), neonatal deaths n=56(1.0%), admitted neonatal area n=20(0.3%), and stillbirths n=156(2.7%). The risk for death or prolonged admission increases 16% for every 30 s delay in initiating FMV up to six minutes (p=0.045) and 6% for every minute of applied FMV (p=0.001). The majority of lifeless babies were in primary apnea and responded to stimulation/suctioning and/or FMV. Infants who required FMV were more likely to die particularly when ventilation was delayed or prolonged. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.
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              Pulse oximetry: technology to reduce child mortality in developing countries.

              The causes of hypoxaemia in children include the commonest causes of childhood illness: pneumonia and other acute respiratory infections, and neonatal illness, particularly sepsis, low birthweight, birth asphyxia and aspiration syndromes. The systematic use of pulse oximetry to monitor and treat children in resource-poor developing countries, when coupled with a reliable oxygen supply, improves quality of care and reduces mortality. Oximetry also has a well established role in surgery and anaesthesia, but in many countries children undergo surgery without the safety of oximetry monitoring. This article reviews pulse oximetry, its technical basis and its application to the medical management of childhood illness to reduce mortality in developing countries. We propose that, as a part of the work towards achieving the Millennium Development Goal 4, there should be a concerted global effort to make pulse oximetry and a reliable oxygen source available in all health facilities where seriously ill children are managed.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                2023
                2 October 2023
                : 12
                : e45512
                Affiliations
                [1 ] Department of Electrical, Computer and Biomedical Engineering Toronto Metropolitan University Toronto, ON Canada
                [2 ] Scarborough Health Network Toronto, ON Canada
                Author notes
                Corresponding Author: Abdelrahman Abdou abdelrahman.abdou@ 123456torontomu.ca
                Author information
                https://orcid.org/0000-0002-7411-1868
                https://orcid.org/0000-0002-4659-564X
                https://orcid.org/0000-0001-7340-9120
                Article
                v12i1e45512
                10.2196/45512
                10580137
                37782528
                a927382d-4215-4d53-ad01-3a87f0f9bb24
                ©Abdelrahman Abdou, Sridhar Krishnan, Niraj Mistry. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 02.10.2023.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 10 July 2023
                : 28 August 2023
                : 2 September 2023
                : 4 September 2023
                Categories
                Protocol
                Protocol

                newborn,electrocardiogram,ecg,dry electrode,heart rate,pediatric,resuscitation,infant,vital signs,neonatal

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