Outpatient Pediatric Pulse Oximeters in Africa
Child, Infant, Respiratory Tract Infections
About this trial
This is an interventional treatment trial for Child
Eligibility Criteria
Inclusion Criteria: 0-59 months of age inclusive presenting to care for an acute condition the includes observed and/or caregiver history of either cough and/or difficult breathing residing in clinic catchment area caregiver agrees to provide contact details including phone number and/or residential address caregiver agrees to be contacted after two weeks by the study staff caregiver is able and willing to provide written informed consent Exclusion Criteria: 60 months of age or older presenting to care for a non-acute condition or an acute condition that does not include either observed or caregiver history of cough and/or difficult breathing does not reside in the clinic catchment area caregiver does not agree to provide contact details caregiver does not agree to be contact by study staff after two weeks caregiver unable to provide written informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
Controls
Phefumla
LB-01
Controls will be managed routinely by the clinic staff, including the triage and clinical examination pathway through the facility, treatment and referral decisions, all of which can include the standard care device. After the child has been given a primary diagnosis and decision on onward care (i.e. referral or home-based management), the study data collector will conduct an exit interview. This interview will include the following topics: the clinical examination conducted by the healthcare worker; current intentions for onward care (e.g. are planning to go to hospital, how are the healthcare worker is travelling); extracting clinical information from the patient medical record - including oxygen saturation measurement. Finally, the study data collector will conduct oxygen saturation measurements using the control device and a reference device.
Phefumla arm participants will be managed by the clinic staff, including the triage and clinical examination pathway through the facility, treatment and referral decisions, all of which can include the Phefumla device. After the child has been given a primary diagnosis and decision on onward care (i.e. referral or home-based management), the study data collector will conduct an exit interview. This interview will include the following topics: the clinical examination conducted by the healthcare worker; current intentions for onward care (e.g. if planning to go to hospital, how is the healthcare worker is travelling); extracting clinical information from the patient medical record - including oxygen saturation measurement. Finally, the study data collector will conduct oxygen saturation measurements using the Phefumla device and a reference device.
LB-01 arm participants will be managed by the clinic staff, including the triage and clinical examination pathway through the facility, treatment and referral decisions, all of which can include the LB-01 device. After the child has been given a primary diagnosis and decision on onward care (i.e. referral or home-based management), the study data collector will conduct an exit interview. This interview will include the following topics: the clinical examination conducted by the healthcare worker; current intentions for onward care (e.g. are if planning to go to hospital, how is the healthcare worker travelling); extracting clinical information from the patient medical record - including oxygen saturation measurement. Finally, the study data collector will conduct oxygen saturation measurements using the LB-01 device and a reference device.