Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol
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 outcom...
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BMJ Publishing Group
2020-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/4/e035184.full |
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| author | Amy Sarah Ginsburg Evangelyn Nkwopara Shuai Xu J Mark Ansermino William Macharia Roseline Ochieng Mary Waiyego Guohai Zhou Roman Karasik |
| author_facet | Amy Sarah Ginsburg Evangelyn Nkwopara Shuai Xu J Mark Ansermino William Macharia Roseline Ochieng Mary Waiyego Guohai Zhou Roman Karasik |
| author_sort | Amy Sarah Ginsburg |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a8fce5e860034f9bab817b8f0a307a2a |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-04-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-a8fce5e860034f9bab817b8f0a307a2a2025-08-20T02:19:51ZengBMJ Publishing GroupBMJ Open2044-60552020-04-0110410.1136/bmjopen-2019-035184Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocolAmy Sarah Ginsburg0Evangelyn Nkwopara1Shuai Xu2J Mark Ansermino3William Macharia4Roseline Ochieng5Mary Waiyego6Guohai Zhou7Roman Karasik8International Programs, Save the Children Federation, Fairfield, Connecticut, USAInternational Programs, Save the Children Federation, Fairfield, Connecticut, USADermatology, Northwestern University, Evanston, Illinois, USA1 Department of Anesthesiology, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, British Columbia, CanadaPediatrics, Aga Khan University, Nairobi, Kenya2 Department of Pediatrics, Aga Khan University, Nairobi, KenyaPediatrics, Pumwani Maternity Hospital, Nairobi, Kenya5 Center for Clinical Investigation, Brigham and Women’s Hospital, Boston, Massachusetts, USA3 EarlySense, Ramat Gan, Tel Aviv, IsraelIntroduction 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.https://bmjopen.bmj.com/content/10/4/e035184.full |
| spellingShingle | Amy Sarah Ginsburg Evangelyn Nkwopara Shuai Xu J Mark Ansermino William Macharia Roseline Ochieng Mary Waiyego Guohai Zhou Roman Karasik Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol BMJ Open |
| title | Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol |
| title_full | Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol |
| title_fullStr | Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol |
| title_full_unstemmed | Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol |
| title_short | Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol |
| title_sort | evaluation of non invasive continuous physiological monitoring devices for neonates in nairobi kenya a research protocol |
| url | https://bmjopen.bmj.com/content/10/4/e035184.full |
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