Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT03067558
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
59 Months
Study:
NCT03067558
Study Brief:
Protocol Section:
NCT03067558