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Evaluation of Technologies for Neonates in Africa (ETNA)

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ClinicalTrials.gov Identifier: NCT03920761
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
Aga Khan University
University of British Columbia
EarlySense Ltd.
SWICA
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Save the Children

Brief 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.

Condition or disease Intervention/treatment
Neonatal Physiology Device: EarlySense Insight system Device: Advanced Neonatal Epidermal System

Detailed Description:
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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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Technologies for Neonates in Africa
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Determine the accuracy the investigational devices: Agreement of the relevant measurement [ Time Frame: Measurements will be collected at one minute intervals for a minimum of 1 hour ]
    Agreement of the relevant measurement parameters of interest between the investigational device and the reference device(s) at each observation

  2. Determine the clinical feasibility of the investigational devices: Agreement of clinical event detection [ Time Frame: Measurements collected at one minute intervals for a minimum of 1 hour ]
    Agreement of clinical event detection between the investigational device and the reference device(s) at each observation.

  3. Assess the feasibility, usability and acceptability of the investigational device: questionnaire [ Time Frame: One 30 minute in-depth interview ]
    Qualitative questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Neonates enrolled in the study will be representative of the ethnic demographics in Nairobi, Kenya. Both female and male neonates will be enrolled.
Criteria

Inclusion Criteria:

  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.

Exclusion Criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920761


Contacts
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Contact: Amy Ginsburg, MD, MPH 206-258-1827 aginsburg@savechildren.org

Locations
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Kenya
Aga Khan University Hospital, Nairobi Recruiting
Nairobi, Kenya
Contact: William Macharia, MD         
Principal Investigator: William Macharia, MD         
Sub-Investigator: Roseline Ochieng, MBChB, MMed         
Pumwani Maternity Hospital Not yet recruiting
Nairobi, Kenya
Contact: William Macharia, MD         
Sub-Investigator: Mary Waiyego, MBChB,MMed         
Sponsors and Collaborators
Save the Children
Aga Khan University
University of British Columbia
EarlySense Ltd.
SWICA
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Amy Ginsburg, MD, MPH Save the Children
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Save the Children
ClinicalTrials.gov Identifier: NCT03920761    
Other Study ID Numbers: ETNA
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No