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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
South Africa
Desmond Tutu TB Centre
RECRUITING
Cape Town
Contact Information
Primary
Eric D McCollum, MD MPH
emccoll3@jhmi.edu
+27790669233
Backup
Carina King, PhD
carina.king@ki.se
+46852480000
Time Frame
Start Date: 2024-11-04
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 1200
Treatments
No_intervention: Controls
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 had an oxygen saturation measurement, the study data collector will conduct oxygen saturation measurements using the control device and a reference device.
Experimental: Phefumla
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 had an oxygen saturation measurement, the study data collector will conduct oxygen saturation measurements using the Phefumla device and a reference device. All final patient clinical management decisions will be made based on the reference device measurement.
Experimental: LB-01
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 had an oxygen saturation measurement, the study data collector will conduct oxygen saturation measurements using the LB-01 device and a reference device.
Related Therapeutic Areas
Sponsors
Collaborators: Karolinska Institutet, Thrasher Research Fund, University of Stellenbosch, Fogarty International Center of the National Institute of Health, Baylor College of Medicine
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov