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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Evaluation of Technologies for Neonates in Africa

Clinicaltrials.gov identifier NCT03920761

Recruitment Status Completed

First Posted April 19, 2019

Last update posted February 17, 2021

Study Description

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:Neonatal Physiology
  • Intervention/Treatment: Device: EarlySense Insight system
    Device: Advanced Neonatal Epidermal System
  • Phase: N/A
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.

Study Design
  • Study Type: Observational
  • Actual Enrollment: 575 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Evaluation of Technologies for Neonates in Africa
  • Actual Study Start Date: June 2019
  • Actual Primary Completion Date: December 2020
  • Actual Study Completion Date: December 2020
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: up to 28 / (18 to 64 years)
  • 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.

Contacts and Locations
Contacts
Locations

Kenya
Aga Khan University Hospital, Nairobi
Nairobi

Kenya
Pumwani Maternity Hospital
Nairobi

Sponsors and Collaborators

Save the Children

Aga Khan University

University of British Columbia

EarlySense Ltd.

SWICA

Bill and Melinda Gates Foundation

Investigators

Principal Investigator: Mark Ansermino BC Children's Hospital, Canada

More Information