Evaluation of Technologies for Neonates in Africa

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Technologies for Neonates in Africa

Conditions
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Neonatal Physiology

Intervention / Treatment
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* Device: EarlySense Insight system
* Device: Advanced Neonatal Epidermal System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Receiving mechanical ventilation or continuous positive airway pressure (CPAP). Skin abnormalities in the nasopharynx and/or oropharynx. Contraindication to application of skin sensors. Known arrhythmia. 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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: EarlySense Insight system|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |