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Recruiting NCT05914324

Outpatient Pediatric Pulse Oximeters in Africa

Trial Parameters

Condition Child
Sponsor Johns Hopkins University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,200
Sex ALL
Min Age 0 Months
Max Age 23 Months
Start Date 2024-11-04
Completion 2026-04-30
Interventions
Phefumla deviceLB-01 device

Brief Summary

The primary objective of this clinical trial is to evaluate the performance of three pulse oximeters during outpatient care within Cape Town, South Africa. This objective will be achieved through generating evidence on how, why, for whom, to what extent and at what cost can paediatric pulse oximetry devices improve the management of hypoxemic children. This will be done with two inter-linked studies: * Aim 1: Determine the impact of two novel paediatric pulse oximeter devices on the correct management of hypoxaemia. * Aim 2: Describe the burden of hypoxaemia and risks for mortality amongst children presenting with acute respiratory infections in a low-resource setting in Cape Town.

Eligibility Criteria

Inclusion Criteria: * 0 to \<24 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: * 24 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

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