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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03920761
Recruitment Status Completed
First Posted April 19, 2019
Last update posted February 17, 2021
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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1. Male or female neonate, corrected age of ≤ 28 days.
2. Willingness and ability of neonate's caregiver to provide informed consent and to be
available for follow-up for the planned duration of the study.
1. Receiving mechanical ventilation or continuous positive airway pressure (CPAP).
2. Skin abnormalities in the nasopharynx and/or oropharynx.
3. Contraindication to application of skin sensors.
4. Known arrhythmia.
5. Presence of a congenital abnormality requiring major surgical intervention.
6. Any medical or psychosocial condition or circumstance that, in the opinion of the
investigators, would interfere with the conduct of the study or for which study
participation might jeopardize the neonate's health.
Aga Khan University Hospital, Nairobi
Pumwani Maternity Hospital
Save the Children
Aga Khan University
University of British Columbia
Bill and Melinda Gates Foundation
Principal Investigator: Mark Ansermino BC Children's Hospital, Canada
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.