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Evaluation of Technologies for Neonates in Africa

NCT03920761 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 575

Last updated 2021-02-17

No results posted yet for this study

Summary

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.

Conditions

  • Neonatal Physiology

Interventions

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.

Sponsors & Collaborators

  • Aga Khan University

    collaborator OTHER

  • University of British Columbia

    collaborator OTHER

  • EarlySense Ltd.

    collaborator INDUSTRY

  • SWICA

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Save the Children

    lead OTHER

Principal Investigators

  • Mark Ansermino · BC Children's Hospital, Canada

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-27
Primary Completion
2020-12-15
Completion
2020-12-30
FDA Device
Yes

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03920761 on ClinicalTrials.gov