|Evaluation of Technologies for Neonates in Africa|
|Clinicaltrials.gov identifier||recruitment status||First Posted||Last update posted|
|NCT03920761||Completed||April 19, 2019||February 17, 2021|
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|
Device: EarlySense Insight system
Device: Advanced Neonatal Epidermal System
To further reduce neonatal mortality rate in low resource settings (LRS) in Africa, research
|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 ]
|Ages Eligible for Study:||up to 28 / (18 to 64 years)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
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.
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|
|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|
|Bill and Melinda Gates Foundation|
|Principal Investigator :||Mark Ansermino||BC Children's Hospital, Canada|
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.
|Responsible Party :||Save the Children|
|ClinicalTrials.gov Identifier :||NCT03920761|
|Other Study ID Numbers :||ETNA|
|First Posted :||April 19, 2019|
|Last Update Posted :||February 17, 2021|
|Last Verified :||February 2021|
Data (IPD) Sharing
|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.|
|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.:||Yes|