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

NCT03067558 | Terminated

• 1 other identifier: 43207799
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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.

Conditions

Pneumonia Childhood

Keywords

Pneumonia; Diagnostics; Childhood; Respiratory rate; Ethiopia

Outcome Measures

Primary Outcomes (2)

• Accuracy of ARIDA test device in children under 5 years with cough or difficulty breathing in a controlled setting.

  Mean difference with standard deviation (precision) between ARIDA test device and simultaneous reference standard RR results.

  Up to 300 seconds

• Consistency of ARIDA test device in children under 5 years with cough or difficulty breathing in a controlled setting.

  Mean difference with standard deviation of respiratory rate readings obtained by two simultaneous ARIDA test devices.

  Up to 300 seconds

Secondary Outcomes (3)

• Accuracy of expert clinician using standard practice (manual ARI timer) in children under 5 years with cough or difficulty breathing in a controlled setting.

  60 seconds

• Consistency of expert clinician using standard practice (manual acute respiratory infection timer) in children under 5 years with cough or difficulty breathing in a controlled setting.

  60 seconds

• Respiratory rate fluctuation over time after ARIDA test device attachment in normal breathing children aged 2 to 59 months, in a controlled setting.

  300 seconds

Study Arms (3)

Accuracy evaulation

Three age groups (young infants 0 to \<2 months, children 2 to \<12 months and 12 to 59 months) will participate in the accuracy evaluation. Participants will be enrolled in a ratio 3:1 fast to normal breathers, by age group. Respiratory rate evaluations will be done using the ARIDA test device and the MK2 ARI timer (standard practice).

Diagnostic Test: Children's automated respiratory rate monitor; Diagnostic Test: MK2 Acute Respiratory Infection (ARI) Timer

Consistency evaluation

Two age groups (children 2 to \<12 months and 12 to 59 months) will participate in the consistency evaluation. Participants will be enrolled in a ratio 3:1 fast to normal breathers, by age group. Respiratory rate evaluations will be done using the ARIDA test device and the MK2 ARI timer (standard practice).

Diagnostic Test: Children's automated respiratory rate monitor; Diagnostic Test: MK2 Acute Respiratory Infection (ARI) Timer

Respiratory rate fluctuation evaulation

Two age groups (children 2 to \<12 months and 12 to 59 months) will participate in the respiratory rate fluctuation evaluation. All participants will be normal breathers.Respiratory rate evaluations will be done using the MK2 ARI timer (standard practice). The ARIDA test device will be strapped to the child during the manual RR count with MK2 ARI timer (standard practice).

Diagnostic Test: MK2 Acute Respiratory Infection (ARI) Timer

Interventions

Children's automated respiratory rate monitor DIAGNOSTIC_TEST

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.

Also known as: ChARM

Accuracy evaulation; Consistency evaluation

MK2 Acute Respiratory Infection (ARI) Timer DIAGNOSTIC_TEST

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.

Accuracy evaulation; Consistency evaluation; Respiratory rate fluctuation evaulation

Eligibility Criteria

• Age: Up to 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study subjects will be: 1. Children under 5 years of age attending outpatient or in-patient departments at the selected hospital (St Paul's Hospital, Addis Ababa). 2. Two ECs with extensive experience in assessing and treating children with fast breathing pneumonia using IMNCI guidelines, selected based on education, training and years of experience.

You may qualify if:

• A child (2 to 59 months) who fulfils ALL of the following eligibility criteria will be included in the accuracy and consistency evaluations:
• Age 2 to 59 months
• Cough or difficulty breathing
• Parent or Guardian consent
• A young infant (0 to \<2 months) who fulfils ALL of the following eligibility criteria will be included in the accuracy evaluation:
• Age 0 to \<2 months
• Parent or Guardian consent
• A child who fulfils ALL of the following eligibility criteria will be included in the respiratory rate fluctuation evaluation:
• Age 2 to 59 months
• Parent or Guardian consent
• Normal breathing

You may not qualify if:

• A child/young infant with the following criteria will be excluded from all elements of this study:
• General danger signs:
• Newborns (\<28 days): not feeding well, active convulsions/fits, chest indrawing, fever (37.5 degrees or more), low body temperature (less than 35.5 degrees) or movement only when stimulated/no movement at all.
• All other age groups: active convulsions/fits, unconscious/lethargic, not breastfeeding/not drinking or vomiting everything.
• Signs of severe pneumonia:
• Chest indrawing or
• Stridor in a calm child
• IMNCI pink referral signs for severe disease including stridor, severe dehydration, severe persistent diarrhoea, very severe febrile disease, severe complicated measles, mastoiditis, complicated severe malnutrition, and severe anaemia.
• Parent or Guardian's age less than 16 years.
• No Parent or Guardian consent.
• If newborn or young infant (\<2months):
• Born before 37 weeks of gestation (pre-term)
• All age groups:
• Wearing supportive device at area of chest/belly
• Skin not intact in chest/belly

Sponsors & Collaborators

• Malaria Consortium: lead
• UNICEF: collaborator
• La Caixa Foundation: collaborator
• Ministry of Health, Ethiopia: collaborator

Study Sites (1)

St. Paul's Hospital Millennium Medical College

Addis Ababa, Ethiopia

Location

Related Publications (1)

• Ward C, Baker K, Marks S, Getachew D, Habte T, McWhorter C, Labarre P, Howard-Brand J, Miller NP, Tarekegn H, Deribessa SJ, Petzold M, Kallander K. Determining the Agreement Between an Automated Respiratory Rate Counter and a Reference Standard for Detecting Symptoms of Pneumonia in Children: Protocol for a Cross-Sectional Study in Ethiopia. JMIR Res Protoc. 2020 Apr 2;9(4):e16531. doi: 10.2196/16531.

  PMID: 32238340 DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Karin Kallander, PhD

  Malaria Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 1, 2017
• Study Start: April 5, 2017
• Primary Completion: May 22, 2017
• Study Completion: May 22, 2017
• Last Updated: July 31, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)