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Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol.

ABSTRACT: INTRODUCTION:Continuous physiological monitoring devices are often not available for monitoring high-risk neonates in low-resource settings. Easy-to-use, non-invasive, multiparameter, continuous physiological monitoring devices could be instrumental in providing appropriate care and improving outcomes for high-risk neonates in these low-resource settings. METHODS AND ANALYSIS:The purpose of this prospective, observational, facility-based evaluation is to provide evidence to establish whether two existing non-invasive, multiparameter, continuous physiological monitoring devices developed by device developers, EarlySense and Sibel, can accurately and reliably measure vital signs in neonates (when compared with verified reference devices). We will also assess the feasibility, usability and acceptability of these devices for use in neonates in low-resource settings in Africa. Up to 500 neonates are enrolled in two phases: (1) a verification and accuracy evaluation phase at Aga Khan University-Nairobi and (2) a clinical feasibility evaluation phase at Pumwani Maternity Hospital in Nairobi, Kenya. Both quantitative and qualitative data are collected and analysed. Agreement between the investigational and reference devices is determined using a priori-defined accuracy thresholds. ETHICS AND DISSEMINATION:This trial was approved by the Aga Khan University Nairobi Research Ethics Committee and the Western Institutional Review Board. We plan to disseminate research results in peer-reviewed journals and international conferences. TRIAL REGISTRATION NUMBER:NCT03920761.

SUBMITTER: Ginsburg AS

PROVIDER: S-EPMC7200030 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol.

Ginsburg Amy Sarah AS Nkwopara Evangelyn E Macharia William W Ochieng Roseline R Waiyego Mary M Zhou Guohai G Karasik Roman R Xu Shuai S Ansermino J Mark JM

BMJ open 20200412 4

<h4>Introduction</h4>Continuous physiological monitoring devices are often not available for monitoring high-risk neonates in low-resource settings. Easy-to-use, non-invasive, multiparameter, continuous physiological monitoring devices could be instrumental in providing appropriate care and improving outcomes for high-risk neonates in these low-resource settings.<h4>Methods and analysis</h4>The purpose of this prospective, observational, facility-based evaluation is to provide evidence to establ ...[more]

PMID: 32284391

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Project description:BackgroundContinuous physiological monitoring technologies are important for strengthening hospital care for neonates, particularly in resource-constrained settings, and understanding user perspectives is critical for informing medical technology design, development, and optimization.ObjectiveThis study aims to assess the feasibility, usability, and acceptability of 2 noninvasive, multiparameter, continuous physiological monitoring technologies for use in neonates in an African health care setting.MethodsWe assessed 2 investigational technologies from EarlySense and Sibel, compared with the reference Masimo Rad-97 technology through in-depth interviews and direct observations. A purposive sample of health care administrators, health care providers, and caregivers at Aga Khan University Hospital, a tertiary, private hospital in Nairobi, Kenya, were included. Data were analyzed using a thematic approach in NVivo 12 software.ResultsBetween July and August 2020, we interviewed 12 health care providers, 5 health care administrators, and 10 caregivers and observed the monitoring of 12 neonates. Staffing and maintenance of training in neonatal units are important feasibility considerations, and simple training requirements support the feasibility of the investigational technologies. Key usability characteristics included ease of use, wireless features, and reduced number of attachments connecting the neonate to the monitoring technology, which health care providers considered to increase the efficiency of care. The main factors supporting acceptability included caregiver-highlighted perceptions of neonate comfort and health care respondent technology familiarity. Concerns about the side effects of wireless connections, electromagnetic fields, and mistrust of unfamiliar technologies have emerged as possible acceptability barriers to investigational technologies.ConclusionsOverall, respondents considered the investigational technologies feasible, usable, and acceptable for the care of neonates at this health care facility. Our findings highlight the potential of different multiparameter continuous physiological monitoring technologies for use in different neonatal care settings. Simple and user-friendly technologies may help to bridge gaps in current care where there are many neonates; however, challenges in maintaining training and ensuring feasibility within resource-constrained health care settings warrant further research.International registered report identifier (irrid)RR2-10.1136/bmjopen-2019-035184.

Project description:Clinically feasible multiparameter continuous physiological monitoring technologies are needed for use in resource-constrained African healthcare facilities to allow for early detection of critical events and timely intervention for major morbidities in high-risk neonates. We conducted a prospective clinical feasibility study of a novel multiparameter continuous physiological monitoring technology in neonates at Pumwani Maternity Hospital in Nairobi, Kenya. To assess feasibility, we compared the performance of Sibel's Advanced Neonatal Epidermal (ANNE) technology to reference technologies, including Masimo's Rad-97 pulse CO-oximeter with capnography technology for heart rate (HR), respiratory rate (RR), and oxygen saturation (SpO2) measurements and Spengler's Tempo Easy non-contact infrared thermometer for temperature measurements. We evaluated key performance criteria such as up-time, clinical event detection performance, and the agreement of measurements compared to those from the reference technologies in an uncontrolled, real-world setting. Between September 15 and December 15, 2020, we collected and analyzed 503 h of ANNE data from 109 enrolled neonates. ANNE's up-time was 42 (11%) h more for HR, 77 (25%) h more for RR, and 6 (2%) h less for SpO2 compared to the Rad-97. However, ANNE's ratio of up-time to total attached time was less than Rad-97's for HR (0.79 vs 0.86), RR (0.68 vs. 0.79), and SpO2 (0.69 vs 0.86). ANNE demonstrated adequate performance in identifying high and low HR and RR and high temperature events; however, showed relatively poor performance for low SpO2 events. The normalized spread of limits of agreement were 8.4% for HR and 52.2% for RR and the normalized root-mean-square deviation was 4.4% for SpO2. Temperature agreement showed a spread of limits of agreement of 2.8 °C. The a priori-identified optimal limits were met for HR and temperature but not for RR or SpO2. ANNE was clinically feasible for HR and temperature but not RR and SpO2 as demonstrated by the technology's up-time, clinical event detection performance, and the agreement of measurements compared to those from the reference technologies.

Project description:ObjectiveTo assess the feasibility, usability and acceptability of two non-invasive, multiparameter, continuous physiological monitoring (MCPM) technologies for use in neonates within a resource-constrained healthcare setting in sub-Saharan Africa.DesignA qualitative study using in-depth interviews and direct observations to describe healthcare professional and caregiver perspectives and experiences with investigational MCPM technologies from EarlySense and Sibel compared with selected reference technologies.SettingPumwani Maternity Hospital is a public, high-volume, tertiary hospital in Nairobi, Kenya.ParticipantsIn-depth interviews were conducted with five healthcare administrators, 12 healthcare providers and 10 caregivers. Direct observations were made of healthcare providers using the technologies on 12 neonates overall.ResultsDesign factors like non-invasiveness, portability, ease-of-use and ability to measure multiple vital signs concurrently emerged as key themes supporting the usability and acceptability of the investigational technologies. However, respondents also reported feasibility challenges to implementation, including overcrowding in the neonatal unit, lack of reliable access to electricity and computers, and concerns about cost and maintenance needs. To improve acceptability, respondents highlighted the need for adequate staffing to appropriately engage caregivers and dispel misconceptions about the technologies.ConclusionStudy participants were positive about the usefulness of the investigational technologies to strengthen clinical care quality and identification of at-risk neonates for better access to timely interventions. These technologies have the potential to improve equity of access to appropriate healthcare services and neonatal outcomes in sub-Saharan African healthcare facilities. However, health system strengthening is also critical to support sustainable uptake of technologies into routine care.Trial registration numberNCT03920761.

Project description:ObjectiveWe evaluated the impact of monitoring indication, early electroencephalography (EEG), and clinical features on seizure risk in all neonates undergoing continuous EEG (cEEG) monitoring following a standardized monitoring protocol.MethodsAll cEEGs from unique neonates 34-48 weeks postmenstrual age monitored from 1/2011-10/2017 (n = 291) were included. We evaluated the impact of cEEG monitoring indication (acute neonatal encephalopathy [ANE], suspicious clinical events [SCEs], or other high-risk conditions [OHRs]), age, medication status, and early EEG abnormalities (including the presence of epileptiform discharges and abnormal background continuity, amplitude, asymmetry, asynchrony, excessive sharp transients, and burst suppression) on time to first seizure and overall seizure risk using Kaplan-Meier survival curves and multivariable Cox proportional hazards models.ResultsSeizures occurred in 28% of high-risk neonates. Discontinuation of monitoring after 24 hours of seizure-freedom would have missed 8.5% of neonates with seizures. Overall seizure risk was lower in neonates monitored for ANE compared to OHR (P = .004) and trended lower compared to SCE (P = .097). The time course of seizure presentation varied by group, where the probability of future seizure was less than 1% after 17 hours of seizure-free monitoring in the SCE group, but required 42 hours in the OHR group, and 73 hours in the ANE group. The presence of early epileptiform discharges increased seizure risk in each group (ANE: adjusted hazard ratio [aHR] 4.32, 95% confidence interval [CI] 1.23-15.13, P = .022; SCE: aHR 10.95, 95% CI 4.77-25.14, P < 1e-07; OHR: aHR 56.90, 95% CI 10.32-313.72, P < 1e-05).SignificanceNeonates who undergo cEEG are at high risk for seizures, and risk varies by monitoring indication and early EEG findings. Seizures are captured in nearly all neonates undergoing monitoring for SCE within 24 hours of cEEG monitoring. Neonates monitored for OHR and ANE can present with delayed seizures and require longer durations of monitoring. Early epileptiform discharges are the best early EEG feature to predict seizure risk.

Project description:INTRODUCTION:Rapid urbanisation in Kenya has resulted in growth of slums in urban centres, characterised by poverty, inadequate social services and poor health outcomes. The government's initiatives to improve access to quality healthcare for mothers and children are largely limited to public health facilities, which are few and/or inaccessible in underserved areas such as the slums. The 'Partnership for Maternal, Newborn and Child Health' (PAMANECH) project is being implemented in two Nairobi slums, Viwandani and Korogocho, to assess the impact of strengthening public-private partnerships for the delivery of healthcare on the health of mothers, newborns and young children in two informal settlements in Kenya. METHODS AND ANALYSIS:This is a quasi-experimental study; our approach is to support private as well as public health providers and the community to enhance access to and demand for quality healthcare services. Key activities include: infrastructural upgrade of selected Private Not-For-Profit health facilities operating in the two slums, building capacity for healthcare providers as well as the Health Management Teams in Nairobi, facilitating provision of supportive supervision by the local health authorities and forming networks of Community Health Volunteers (CHVs) to create demand for health services. To assess the impact of the intervention, the study is utilising multiple data sources using a combination of qualitative and quantitative methods. A baseline survey was conducted in 2013 and an end-line survey will be conducted at least 1 year after full implementation of the intervention. Systematic monitoring and documentation of the intervention is on-going to strengthen the case for causal inference. ETHICS AND DISSEMINATION:Ethical approval for the study was obtained from the Kenya Medical Research Institute. Key messages from the results will be packaged and widely disseminated through workshops, conference presentations, reports, factsheets and academic publications to facilitate uptake by policymakers. PROTOCOL REGISTRATION NUMBER:KEMRI- NON-SSC-PROTOCOL No. 393.

Project description:Background: Research site monitoring (RSM) is an effective way to ensure compliance with Good Clinical Practice (GCP). However, RSM is not offered to trainees (investigators) at African Institutions routinely. The Makerere University/Uganda Virus Research Institute Centre of Excellence in Infection and Immunity Research and Training (MUII-Plus) introduced internal monitoring to promote the quality of trainees' research projects. Here, we share our monitoring model, experiences and achievements, and challenges encountered. Methods: We analysed investigators' project reports from monitoring visits undertaken from April 2017 to December 2019. Monitors followed a standard checklist to review investigator site files and record forms, and toured site facilities. We planned four monitoring visits for each trainee: one at site initiation, two interim, and a closeout monitoring visit. A team of two monitors conducted the visits. Results: We monitored 25 out of the 26 research projects in progress between April 2017 and December 2019. Compliance with protocols, standard operating procedures, GCP, and GCLP improved with each monitoring visit. Median (IQR) compliance rate was 43% (31%, 44%) at site initiation visit for different monitoring items, 70% (54%, 90%) at the 1st interim monitoring visit, 100% (92%, 100%) at 2nd interim monitoring visit and all projects achieved 100% compliance at site closeout. All investigators had good work ethics and practice, and appropriate facilities. Initially, some investigators' files lacked essential documents, and informed consent processes needed to be improved. We realized that non-compliant investigators had not received prior training in GCP/GCLP, so we offered them this training. Conclusions: Routine monitoring helps identify non-compliance early and improves the quality of research. We recommend continuous internal monitoring for all research studies. Investigators conducting research involving human subjects should receive GCP/GCLP training before commencing their projects. Institutional higher degrees and research ethics committees should enforce this as a requirement for project approvals.

Dataset Information

Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol.

Publications

Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol.

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