Evaluation of Technologies for Neonates in Africa

Neonatal Physiology Clinical Trial

— ETNA  

Official title:

Evaluation of Technologies for Neonates in Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920761
• Other study ID #: ETNA
• Status: Completed
• Start date: June 27, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2021
• Source: Save the Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 575
• Est. completion date: December 30, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Neonatal Physiology

Intervention

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
• 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.

Locations

Country	Name	City	State
Kenya	Aga Khan University Hospital, Nairobi	Nairobi
Kenya	Pumwani Maternity Hospital	Nairobi

Sponsors (6)

Lead Sponsor	Collaborator
Save the Children	Aga Khan University, Bill and Melinda Gates Foundation, EarlySense Ltd., SWICA, University of British Columbia

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Assess the feasibility, usability and acceptability of the investigational device: questionnaire	Qualitative questionnaire	One 30 minute in-depth interview