NCT03265756

Brief Summary

Pneumonia is a major cause of illness in young children. The investigators are developing and testing a new thermometer like device called Multimometer, to measure the respiration rate (RR), temperature, heart rate (HR) and the degree of blood oxygenation (SpO2) of children who may suffer from pneumonia. These are called vital signs and their measurements greatly help to diagnose pneumonia. In the first part of the study, and in order to optimize and better align the size of the device with the face, the investigators will measure the average size and dimensions of young children's face. In the second part of the study, the investigators will compare the vital signs measurements with measurements obtained by other commonly used devices in ill children who are suspected to suffer from pneumonia.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
2 countries

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

Study Start

First participant enrolled

June 20, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

August 26, 2017

Last Update Submit

November 19, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Vital Signs Comparison

    Measurements of respiration rate, temperature, heart rate and the degree of blood oxygenation of children

    2018

Secondary Outcomes (1)

  • 3D facial images

    2017-2018

Study Arms (2)

Healthy children

250 3D facial images of healthy children under 5yrs of age in the Democratic Republic of Congo (DRC).

Suspected Pneumonia

50 young children (under 5 yrs) in hospital/clinics in Butembo DRC with suspected pneumonia

Device: Multimometer

Interventions

A device for measuring respiration rate, temperature, heart rate and the degree of blood oxygenation of children

Suspected Pneumonia

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children under 5y of age

You may qualify if:

  • For the first part of the study (3D facial images):
  • Healthy children under 5y of age
  • For the second phase of the study (Comparison of vital signs):
  • Children under 5y of age with suspected pneumonia

You may not qualify if:

  • Children older than 5y of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G2C6, Canada

Location

AHFIA (Association for Health Innovation in Africa)

Butembo, North Kivu, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Israel Amirav

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 26, 2017

First Posted

August 29, 2017

Study Start

June 20, 2017

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

November 21, 2018

Record last verified: 2018-11

Locations