Outpatient Pediatric Pulse Oximeters in Africa

NARecruitingINTERVENTIONAL
Enrollment

1,200

Participants

Timeline

Start Date

November 4, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
ChildInfantRespiratory Tract InfectionsHypoxia
Interventions
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.

Trial Locations (1)

7505

RECRUITING

Desmond Tutu TB Centre, Cape Town

All Listed Sponsors
collaborator

University of Stellenbosch

OTHER

collaborator

Karolinska Institutet

OTHER

collaborator

Baylor College of Medicine

OTHER

collaborator

Fogarty International Center of the National Institute of Health

NIH

collaborator

Thrasher Research Fund

OTHER

lead

Johns Hopkins University

OTHER