Evaluation of Technologies for Neonates in Africa (ETNA)

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Physiology
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 575

Contacts and Locations

Study Locations

• Kenya
  • Nairobi, Kenya
    • Aga Khan University Hospital, Nairobi
  • Nairobi, Kenya
    • Pumwani Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Save the Children
• Collaborators: University of British Columbia; Bill and Melinda Gates Foundation; Aga Khan University; EarlySense Ltd.; SWICA
• Investigators: Principal Investigator: Mark Ansermino, BC Children's Hospital, Canada

Publications and helpful links

General Publications

• Kinshella MW, Naanyu V, Chomba D, Waiyego M, Rigg J, Coleman J, Hwang B, Ansermino JM, Macharia WM, Ginsburg AS. Qualitative study exploring the feasibility, usability and acceptability of neonatal continuous monitoring technologies at a public tertiary hospital in Nairobi, Kenya. BMJ Open. 2022 Jan 11;12(1):e053486. doi: 10.1136/bmjopen-2021-053486.
• Wang D, Macharia WM, Ochieng R, Chomba D, Hadida YS, Karasik R, Dunsmuir D, Coleman J, Zhou G, Ginsburg AS, Ansermino JM. Evaluation of a contactless neonatal physiological monitor in Nairobi, Kenya. Arch Dis Child. 2022 Jun;107(6):558-564. doi: 10.1136/archdischild-2021-322344. Epub 2021 Nov 5.
• Ginsburg AS, Nkwopara E, Macharia W, Ochieng R, Waiyego M, Zhou G, Karasik R, Xu S, Ansermino JM. Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol. BMJ Open. 2020 Apr 12;10(4):e035184. doi: 10.1136/bmjopen-2019-035184.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ETNA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.

Drug and device information, study documents

• 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