Clinical trial NCT03920761: Evaluation of Technologies for Neonates in Africa
Official title: Evaluation of Technologies for Neonates in Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Physiology
Lead sponsor: Save the Children
Sponsor class: OTHER
Collaborators: name: Aga Khan University
name: University of British Columbia
name: EarlySense Ltd.
name: SWICA
name: Bill and Melinda Gates Foundation
First posted: 2019-04-19
Enrollment: 575
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Determine the accuracy the investigational devices: Agreement of the relevant measurement
timeFrame: Measurements will be collected at one minute intervals for a minimum of 1 hour
measure: Determine the clinical feasibility of the investigational devices: Agreement of clinical event detection
timeFrame: Measurements collected at one minute intervals for a minimum of 1 hour
measure: Assess the feasibility, usability and acceptability of the investigational device: questionnaire
timeFrame: One 30 minute in-depth interview
Secondary outcomes:
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Aga Khan University Hospital, Nairobi
city: Nairobi
country: Kenya
facility: Pumwani Maternity Hospital
Study officials:
affiliation: BC Children's Hospital, Canada
name: Mark Ansermino
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.