Evaluation of Technologies for Neonates in Africa (ETNA)
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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.
Condition or disease
Device: EarlySense Insight systemDevice: Advanced Neonatal Epidermal System
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.
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
Device: Advanced Neonatal Epidermal System
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.
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Layout table for eligibility information
Ages Eligible for Study:
up to 28 Days (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Neonates enrolled in the study will be representative of the ethnic demographics in Nairobi, Kenya. Both female and male neonates will be enrolled.
Male or female neonate, corrected age of ≤ 28 days.
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.
Receiving mechanical ventilation or continuous positive airway pressure (CPAP).
Skin abnormalities in the nasopharynx and/or oropharynx.
Contraindication to application of skin sensors.
Presence of a congenital abnormality requiring major surgical intervention.
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.