Outpatient Pediatric Pulse Oximeters in Africa

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.

Conditions

• Child
• Infant
• Respiratory Tract Infections
• Hypoxia

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.

Sponsors & Collaborators

• University of Stellenbosch

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Fogarty International Center of the National Institute of Health

  collaborator NIH

• Thrasher Research Fund

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Eric McCollum, MD, MPH · Johns Hopkins School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

0 Months

Max Age

23 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-04

Primary Completion

2026-04-30

Completion

2026-12-31

Countries

• South Africa

Study Locations