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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03067558
Recruitment Status : Terminated (Device incorrect colour-coded classification of fast breathing for RR)
First Posted : March 1, 2017
Last Update Posted : July 31, 2017
Sponsor:
Collaborators:
UNICEF
La Caixa Foundation
Ministry of Health, Ethiopia
Information provided by (Responsible Party):
Malaria Consortium

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. 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.


Condition or disease Intervention/treatment
Pneumonia Childhood Diagnostic Test: Children's automated respiratory rate monitor Diagnostic Test: MK2 Acute Respiratory Infection (ARI) Timer

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acute Respiratory Infection Diagnostic Aids (ARIDA) for Children Under Five Years When Used in a Controlled Setting in Ethiopia: Study Protocol for Controlled Accuracy Evaluation
Actual Study Start Date : April 5, 2017
Actual Primary Completion Date : May 22, 2017
Actual Study Completion Date : May 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
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

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.

Other Name: ChARM

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.

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

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.

Other Name: ChARM

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.

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
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.




Primary Outcome Measures :
  1. Accuracy of ARIDA test device in children under 5 years with cough or difficulty breathing in a controlled setting. [ Time Frame: Up to 300 seconds ]
    Mean difference with standard deviation (precision) between ARIDA test device and simultaneous reference standard RR results.

  2. Consistency of ARIDA test device in children under 5 years with cough or difficulty breathing in a controlled setting. [ Time Frame: Up to 300 seconds ]
    Mean difference with standard deviation of respiratory rate readings obtained by two simultaneous ARIDA test devices.


Secondary Outcome Measures :
  1. Accuracy of expert clinician using standard practice (manual ARI timer) in children under 5 years with cough or difficulty breathing in a controlled setting. [ Time Frame: 60 seconds ]
    Mean difference with standard deviation between expert clinician and simultaneous reference standard respiratory rate results.

  2. 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. [ Time Frame: 60 seconds ]
    Mean difference with standard deviation of respiratory rate readings obtained by two simultaneous expert clinicians.

  3. Respiratory rate fluctuation over time after ARIDA test device attachment in normal breathing children aged 2 to 59 months, in a controlled setting. [ Time Frame: 300 seconds ]
    Respiratory rate trend before (baseline) and 1, 3, and 5 minutes after ARIDA test device attachment.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion criteria for child in accuracy and consistency evaluations for ARIDA test device and expert clinician:

A child (2 to 59 months) who fulfils ALL of the following eligibility criteria will be included in the accuracy and consistency evaluations:

  1. Age 2 to 59 months
  2. Cough or difficulty breathing
  3. 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:

  1. Age 0 to <2 months
  2. Parent or Guardian consent

Inclusion criteria for child in RR fluctuation evaluations:

A child who fulfils ALL of the following eligibility criteria will be included in the respiratory rate fluctuation evaluation:

  1. Age 2 to 59 months
  2. Parent or Guardian consent
  3. Normal breathing

Exclusion criteria for child/young infant in all elements of the study:

A child/young infant with the following criteria will be excluded from all elements of this study:

  1. General danger signs:

    1. 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.
    2. All other age groups: active convulsions/fits, unconscious/lethargic, not breastfeeding/not drinking or vomiting everything.
  2. Signs of severe pneumonia:

    1. Chest indrawing or
    2. Stridor in a calm child
  3. 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.
  4. Parent or Guardian's age less than 16 years.
  5. No Parent or Guardian consent.

7. Device Manufacturer Safety Exclusion Criteria:

If newborn or young infant (<2months):

  1. Born before 37 weeks of gestation (pre-term)

    All age groups:

  2. Wearing supportive device at area of chest/belly
  3. Skin not intact in chest/belly

In addition, a child with the following criteria will be excluded from the respiratory rate fluctuation evaluation:

  1. Cough or difficult breathing
  2. Fast breathing (see table 2)

Additional exclusion criteria for child/young infant in an in-patient facility:

  1. Child/young infant being managed by barrier nursing (such as severe burns, child with neutropenia, severe infectious diseases).
  2. Child/young infant not eligible for research procedures as advised by the supervising clinician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067558


Locations
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Ethiopia
St. Paul's Hospital Millennium Medical College
Addis Ababa, Ethiopia
Sponsors and Collaborators
Malaria Consortium
UNICEF
La Caixa Foundation
Ministry of Health, Ethiopia
Investigators
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Principal Investigator: Karin Kallander, PhD Malaria Consortium

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Malaria Consortium
ClinicalTrials.gov Identifier: NCT03067558    
Other Study ID Numbers: 43207799
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Malaria Consortium:
Pneumonia
Diagnostics
Childhood
Respiratory rate
Ethiopia
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia
Infection
Lung Diseases
Respiratory Tract Diseases