Evaluation of Technologies for Neonates in Africa

Completed

• Conditions: Neonatal Physiology

• Registration Number: NCT03920761
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-19
• Study Start: 2019-06-27
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 575

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the accuracy the investigational devices: Agreement of the relevant measurement	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
Determine the clinical feasibility of the investigational devices: Agreement of clinical event detection	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.
Assess the feasibility, usability and acceptability of the investigational device: questionnaire	One 30 minute in-depth interview	Qualitative questionnaire

Trial Locations

Locations (2)

Aga Khan University Hospital, Nairobi; 🇰🇪 Nairobi, Kenya

Pumwani Maternity Hospital; 🇰🇪 Nairobi, Kenya