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| Name | Class |
|---|---|
| Aga Khan University | OTHER |
| University of British Columbia | OTHER |
| EarlySense Ltd. | INDUSTRY |
| SWICA |
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This is a diagnostic accuracy evaluation and clinical feasibility study of investigational devices (EarlySense and ANNE systems) in a neonatal high dependency unit (nHDU) in a private teaching hospital and a government maternity hospital in Nairobi, Kenya. Neonates who are admitted for routine observation and care will be enrolled.
To further reduce neonatal mortality rate in low resource settings (LRS) in Africa, research is needed to develop and optimize innovations in neonatal care, specifically technologies that are low cost, operator-independent, and highly efficient. The purpose of this study is to produce information and data regarding the performance of two existing multiparameter continuous physiological monitoring devices developed by device developers, EarlySense and Sonica. The clinical trial is intended to provide evidence to establish whether these investigational devices can reliably and accurately measure vital signs in neonates (when compared to verified reference devices) and to assess the feasibility, usability and acceptability of these devices for use in neonates in a LRS in Africa.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EarlySense Insight system | Device | a small piezoelectric sensor pad that can be placed under the mattress and provide contact-free monitoring by measuring and recording a patient's vital signs and motion parameters | ||
| Advanced Neonatal Epidermal System | Device | a system of neonatal non-invasive adhesive sensors. Sensors are attached directly on the patient's body and are capable of continuously measuring and recording heart rate, respiratory rate, oxygen saturation, and skin temperature. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the accuracy the investigational devices: Agreement of the relevant measurement | Agreement of the relevant measurement parameters of interest between the investigational device and the reference device(s) at each observation | Measurements will be collected at one minute intervals for a minimum of 1 hour |
| Determine the clinical feasibility of the investigational devices: Agreement of clinical event detection | Agreement of clinical event detection between the investigational device and the reference device(s) at each observation. | Measurements collected at one minute intervals for a minimum of 1 hour |
| Assess the feasibility, usability and acceptability of the investigational device: questionnaire | Qualitative questionnaire | One 30 minute in-depth interview |
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Inclusion Criteria:
Exclusion Criteria:
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Neonates enrolled in the study will be representative of the ethnic demographics in Nairobi, Kenya. Both female and male neonates will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Ansermino | BC Children's Hospital, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University Hospital, Nairobi | Nairobi | Kenya | ||||
| Pumwani Maternity Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35017248 | Derived | Kinshella MW, Naanyu V, Chomba D, Waiyego M, Rigg J, Coleman J, Hwang B, Ansermino JM, Macharia WM, Ginsburg AS. Qualitative study exploring the feasibility, usability and acceptability of neonatal continuous monitoring technologies at a public tertiary hospital in Nairobi, Kenya. BMJ Open. 2022 Jan 11;12(1):e053486. doi: 10.1136/bmjopen-2021-053486. | |
| 34740876 |
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If in the future data sharing is needed, the study will establish appropriate data transfer agreements with other researchers and only de-identified data will be shared.
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| OTHER |
| Bill and Melinda Gates Foundation | OTHER |
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| Nairobi |
| Kenya |
| Wang D, Macharia WM, Ochieng R, Chomba D, Hadida YS, Karasik R, Dunsmuir D, Coleman J, Zhou G, Ginsburg AS, Ansermino JM. Evaluation of a contactless neonatal physiological monitor in Nairobi, Kenya. Arch Dis Child. 2022 Jun;107(6):558-564. doi: 10.1136/archdischild-2021-322344. Epub 2021 Nov 5. |
| 32284391 | Derived | Ginsburg AS, Nkwopara E, Macharia W, Ochieng R, Waiyego M, Zhou G, Karasik R, Xu S, Ansermino JM. Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol. BMJ Open. 2020 Apr 12;10(4):e035184. doi: 10.1136/bmjopen-2019-035184. |