Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol
Open accessAbstract
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 .
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Few studies have targeted the challenge of affordable continuous physiological monitoring for at-risk neonates in low-resource settings.
“Affordable, continuous physiological monitoring systems are a crucial tool for early deterioration detection and intervention of at-risk neonates, but few studies have targeted this challenge to improve the quality, access, and efficiency of care to reduce neonatal mortality in low-resource settings20,21.”
From Soft, all-in-one, nanomembrane wearable system for advancing neonatal health monitoring in Ethiopia (2025) · cites this paper as [20]
The Introduction (page unavailable) describes the need for low-cost continuous monitoring devices suitable for neonates in low-resource settings and outlines a project evaluating them. It does not say that few studies have addressed this challenge or assess how much research exists. (LLM, conf=0.82)
Experimental — accuracy not yet measuredAs demonstrated by previous work, neonatal vital signs can also be tracked with the same sensors in both high-resource and low-resource settings as well as support kangaroo care.
“Additionally, as demonstrated by our previous work, neonatal vital signs can also be tracked with the same sensors in both high-resource and low-resource settings as well as support kangaroo care (22, 48).”
From Comprehensive pregnancy monitoring with a network of wireless, soft, and flexible sensors in high- and low-resource health settings (2021) · cites this paper as [48]
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Wearable Sensor Systems for Infants
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Continuous noninvasive monitoring in the neonatal ICU
Sahni, R. (2017) · Current Opinion in Pediatrics · doi:10.1097/mop.0000000000000459 · Cited by 13 · see citing works
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Ryu, D., Kim, D. H., Price, J. T., Lee, J. Y., Chung, H. U., Allen, E., Walter, J. R., Jeong, H., Cao, J., Kulikova, E., et al. (2021) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.2100466118 · Cited by 105 · see citing works
Self-citationGinsburg, A. S., Kinshella, M.-L. W., Naanyu, V., Rigg, J., Chomba, D., Coleman, J., Hwang, B., Ochieng, R., Ansermino, J. M., & Macharia, W. M. (2021) · Journal of Medical Internet Research · doi:10.2196/29755 · Cited by 11 · see citing works
Self-citationSoft, all-in-one, nanomembrane wearable system for advancing neonatal health monitoring in Ethiopia
Zhou, L., Joseph, M., Lee, Y. J., Yadav, D., Nayak, L., Woodall, J., Matthews, J., Soltis, I., Mekuria, F. M., Yeshanew, K. H., et al. (2025) · npj Digital Medicine · doi:10.1038/s41746-025-01974-8 · Cited by 3 · see citing works
“…continuous physiological monitoring systems are a crucial tool for early deterioration detection and intervention of at-risk neonates, but few studies have targeted this challenge to improve the quality, access, and ef fi ciency of care to reduce neonatal mortality in low-resource settings 20,21 .”
- Authors
- Ginsburg, A. S., Nkwopara, E., Macharia, W., Ochieng, R., Waiyego, M., Zhou, G., Karasik, R., Xu, S., & Ansermino, J. M.
- Affiliations
- University of Washington (US)
- Children's Healthcare of Atlanta (US)
- Aga Khan University Nairobi (KE)
- Pediatrics, Pumwani Maternity Hospital, Nairobi, Kenya
- Brigham and Women's Hospital (US)
- EarlySense (Israel) (IL)
- Northwestern University (US)
- University of British Columbia (CA)
- Corresponding author
- Ginsburg, Amy Sarah
- ORCID
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2020-04
- Volume
- 10
- Issue
- 4
- Pages
- e035184
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC7200030
- OpenAlex
- W3015349278
- Cited by
- 16
- References
- 5
- Citations by year
- 2025: 2 · 2024: 1 · 2023: 1 · 2022: 6 · 2021: 6
- FWCI
- 1.02
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMJ Open (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (acceptedVersion)
- HighWire Press Open Archive (acceptedVersion)
- eCommons - AKU (Aga Khan University) (submittedVersion, cc-by)
- Funders
- Bill and Melinda Gates Foundation (OPP1203136)
- Save the Children (Innovation Council)
- Topics
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Health Sciences › Medicine › Surgery › Healthcare Technology and Patient Monitoring
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Development and Preterm Care
- Keywords
- continuous physiological monitoring, high-risk infants, neonatal vital signs, device accuracy, resource-limited settings, multi-parameter monitoring, Nairobi
- MeSH terms
- Wearable Electronic Devices, Attitude of Health Personnel, Feasibility Studies, Heart Rate, Humans, Infant, Newborn, Kenya, Monitoring, Physiologic, Movement, Nurseries, Hospital, Oximetry, Patient Acceptance of Health Care, Skin Temperature, Sleep, Qualitative Research, Vital Signs, Respiratory Rate, Remote Sensing Technology, Observational Studies as Topic
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