NCT03920761

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
575

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 27, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

April 3, 2019

Last Update Submit

February 15, 2021

Conditions

Neonatal Physiology

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

EarlySense Insight systemDEVICE

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 SystemDEVICE

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.

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Male or female neonate, corrected age of ≤ 28 days.
  • 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.

You may not qualify if:

  • Receiving mechanical ventilation or continuous positive airway pressure (CPAP).
  • Skin abnormalities in the nasopharynx and/or oropharynx.
  • Contraindication to application of skin sensors.
  • Known arrhythmia.
  • Presence of a congenital abnormality requiring major surgical intervention.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aga Khan University Hospital, Nairobi

Nairobi, Kenya

Location

Pumwani Maternity Hospital

Nairobi, Kenya

Location

Related Publications (3)

  • 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.

    PMID: 35017248DERIVED

  • 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.

    PMID: 34740876DERIVED

  • 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.

    PMID: 32284391DERIVED

Study Officials

  • Mark Ansermino

    BC Children's Hospital, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 19, 2019

Study Start

June 27, 2019

Primary Completion

December 15, 2020

Study Completion

December 30, 2020

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations

KE(2)