Acute Respiratory Infection Diagnostic Aids (ARIDA) Controlled Accuracy Evaluation Protocol

Summary

Pneumonia is the leading infectious cause of death among children under 5 years of age globally. Many pneumonia deaths result from late care seeking and inappropriate treatment due to misdiagnosis of symptoms. The United Nations Children's Fund's (UNICEF's) Acute Respiratory Infection Diagnostic Aids (ARIDA) project aims to introduce automated respiratory rate (RR) counting aids for use by frontline health workers in resource limited community settings and health facilities. These RR counting aids aim to offer improved accuracy, effectiveness and acceptability compared to current practices for counting and classifying RR to detect fast breathing pneumonia.

The general aim of the controlled accuracy study is to understand whether the ARIDA test device accurately measures RR in children under 5 years of age with cough and/or difficult breathing. It is a cross-sectional, prospective study in a controlled setting comprising three types of device evaluations:

1. The accuracy of the ARIDA test device in measuring RR in young infants 0 to \<2months, children 2 to \<12 months and 12 to 59 months when compared to a video panel reference standard will be established through the first evaluation.
2. The consistency of the ARIDA test device will be established by determining the level of agreement between the measures of RR for two ARIDA test devices when used on the same child at the same time in those aged 2 to \<12 months and 12 to 59 months through the second evaluation.
3. A third evaluation on a different group of normal-breathing children aged 2 to 59 months will assess RR fluctuation over time due to ARIDA test device attachment.

Evaluations 1 and 2 for accuracy and consistency will also be undertaken with expert clinicians (EC) conducting a manual RR count to further the evidence base around the performance of current standard practice in a controlled setting.

The study is a cross-sectional, prospective study and will be conducted in paediatric in and outpatient departments Saint Paul's Hospital and Millennium Medical Collage in Addis Ababa, Ethiopia.

Conditions

• Pneumonia Childhood

Interventions

DIAGNOSTIC_TEST

Children's automated respiratory rate monitor

The "Children's Respiration Monitor" system comprises of an accelerometer based device, with a belt to attach the device to the child. The device measures the respiration rate in children under 5 years old and automatically classifies the breathing rate according to the IMNCI guidelines set by the "World Health Organization". The device is intended to be used by health workers at the community level in low resource settings, clinical officers, nurses, midwives, clinicians (Professional Health Workers) at primary or secondary care facilities.

DIAGNOSTIC_TEST

MK2 Acute Respiratory Infection (ARI) Timer

The MK2 ARI timer is a manual respiratory rate (RR) counting device used to assist frontline health workers in measuring the length of time to count the RR in children. It is the second generation of ARI timers (succeeding MK1 ARI timer). The ARI timer is the standard practice for measuring and classifying RR at community level.

Sponsors & Collaborators

• UNICEF

  collaborator OTHER

• La Caixa Foundation

  collaborator OTHER

• Ministry of Health, Ethiopia

  collaborator OTHER_GOV

• Malaria Consortium

  lead OTHER

Principal Investigators

• Karin Kallander, PhD · Malaria Consortium

Eligibility

Max Age

59 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-04-05

Primary Completion

2017-05-22

Completion

2017-05-22

Countries

• Ethiopia

Study Locations