RECRUITINGINTERVENTIONAL

Outpatient Pediatric Pulse Oximeters in Africa

Evaluating Novel Pediatric Pulse Oximeters for Outpatient Child Pneumonia Care in Sub-Saharan Africa

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

Phefumla device

The Phefumla device uses the Motorola Moto G Power mobile phone. The device utilizes an Android 10 operating system and has 64 gigabyte memory with 4 gigabyte random access memory (RAM). The battery is a 5000 milliampere lithium polymer rechargeable battery, which should last at least 24 hours with minimal phone use. Data can be stored on the device and integration with information systems is planned. The reflectance sensor works on a variety of body parts including the finger, toe, and forehead.

DEVICE

LB-01 device

The LB-01 probe uses transmissive oximetry with the light-emitting diode (LED) and photodetector (PD) positioned opposed to one another when placed on body tissues like fingers, and is used with the Acare pulse oximeter device. The LB-01 probe is an elongated clip sensor with an offset optics location near the hinge, permitting stable positioning on the child's big toe. By incorporating softer hollow silicone pads this design grasps the foot while placing the optics over the toe, to minimize movement artifact, an important issue for child measurements. The soft pads allow comfortable use across the smaller foot of neonates, and the design remains similar enough to a conventional finger sensor that it can be used on adult fingers as well.

Locations (1)

Desmond Tutu TB Centre

Cape Town, Western Cape, South Africa