Outpatient Pediatric Pulse Oximeters in Africa

May 12, 2026 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Lower respiratory tract infections (LRI) remain the leading infectious cause of death globally for children younger than five years.1 Alarmingly, >50% of LRI deaths occurred in low and middle-income countries (LMICs) in sub-Saharan Africa, with inequitable distribution both between and within countries.2 Key quality-of-care implementation gaps have hampered the effectiveness of the World Health Organization (WHO) Integrated Management of Childhood Illnesses (IMCI) guidelines used for pediatric LRI care in LMICs.3 Evaluations of Integrated Management of Childhood Illness (IMCI) guidelines have identified inadequate triaging and therefore results in a failure to identify children at higher risk of death. Interventions to improve the sensitivity and specificity of the IMCI approach in identifying severely ill children could improve outcomes. Routine use of pulse oximetry, to non-invasively measure peripheral oxyhemoglobin saturation (SpO2), is poorly implemented at the primary healthcare (PHC) levels in LMICs, and therefore provides one such opportunity to improve IMCI assessments.

Hypoxemia - a low SpO2, is associated with increased mortality in children with LRI(1).4 Hypoxemia prevalence amongst children with pneumonia in African contexts has been estimated at 28%, and in outpatient settings as 23%.5 As hypoxemia is a key mortality risk factor, effectively identifying these children early in the care-seeking pathway is fundamental to reducing mortality in low-resource contexts.6 While SpO2 is recommended by IMCI for children with suspected pneumonia, pulse oximetry devices for measuring SpO2 are not widely implemented in PHCs in LMICs, where most children first access care. In Malawi 16% of nearly 700 outpatient encounters with suspected LRI had a SpO2 measured, and >40% of children eligible for hospitalization were not referred. Since few children have SpO2 collected during outpatient care, referral decisions are largely based on subjective clinical danger signs. This then has knock-on effects on receipt of oxygen treatment.

While pulse oximetry implementation in PHCs has been slow to scale-up, there is evidence of utility and feasibility. In Malawi, healthcare workers successfully measured the SpO2 on 94% of >14,000 children and were >2 times more likely to correctly refer a child when the child's SpO2 was low. This work also demonstrated >60% of hypoxemic children would not have been referred in the absence of an SpO2 measurement.7 One explanation for slow adoption is the lack of appropriate devices, that have been designed specifically for spot-checks amongst children in outpatient LMIC settings - a population with specific oximetry needs. Important features of such a device are being low cost, robust, able to cope with poor perfusion and motion artefact, good battery life and reliable.8

Mobile phones are relatively inexpensive, widely available, and increasingly utilized for healthcare - 'mobile Health (mHealth)', while electronic Health (eHealth) is when electronic services - like the internet - support healthcare. In LMICs mobile phones offer the potential for expanded healthcare access and quality of care both as a medical device and as a platform for eHealth services, such as the digital health management information system (HMIS) used in sub-Saharan Africa - District Health Information Software 2 (DHIS2). Developing a mobile-based pulse oximeter, with interoperability to store and upload data directly into a patients DHIS2 record has the potential to improve the management of paediatric hypoxaemia. The Phefumela Project, meaning "breathe" in a local South African language, will evaluate the impact of two different novel paediatric pulse oximeters, both designed specifically for this population in a high burden setting in South Africa.

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.

Setting:

The study site is the large Khayelitsha community, which includes 6 primary healthcare clinics (PHCs), 2 community health centers (CHCs), 1 community day centers (CDCs) and one government district hospital serving its catchment area, Khayelitsha Hospital. The nearest tertiary referral government hospital is Tygerberg, which serves 40% of the provincial paediatric population. Khayelitsha township has a population of approximately 450,000 and is 90.5% Black African. Khayelitsha has a very young population, with >40% of its residents under 19 years of age, residing in informal housing with high caregiver unemployment and limited running water access. HIV (human immunodeficiency virus) and tuberculosis prevalence is high; maternal HIV prevalence is 29.5% - the highest in the Western Cape Province - and the tuberculosis incidence of 1,389/100,000 population exceeded the national average of 834/100,000 in 2017.9 Khayelitsha Hospital has an average bed occupancy rate over 130% capacity, and its 47 bed emergency center cares for about 120 patients daily. A 2015 study characterized the pediatric case mix over six months at the emergency center, reporting >80% of pediatric patients were <5 years old, nearly 2/3 were triaged at an emergent level, and the most common diagnosis was LRIs (22.0%, n=70/317). Of 58 children with pneumonia, 5 (8.5%) died.9

Pulse oximeter devices:

The investigators will be using and comparing three different pulse oximeter devices during this study, two (the Phefumla and Lifebox-01 (LB-01) are not commercially available. The Contec device is widely available and currently used clinically in this setting in South Africa. Throughout this study, the Contec device will be considered the reference or control standard.

Study Type

Interventional

Enrollment (Actual)

936

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7505
        • Desmond Tutu TB Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Children with Correct management of oxygen saturation
Time Frame: Day 1
The proportion of children aged 0 to <24 months with acute respiratory infection and (1) a HCW-documented SpO2 and heart rate measured in room air (i.e., off of supplemental oxygen), and (2) an appropriate referral recommendation has been provided by the HCW according to WHO-defined hypoxaemia status (SpO2 <90% or >90%) and (3) SpO2 confirmed by study staff measurement with reference device (within 2% SpO2 range above or below the documented SpO2).
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Children with Correct SpO2 management (definition 2)
Time Frame: Day 1
The proportion of children aged 0 to <24 months with acute respiratory infection and (1) a SpO2 and heart rate measured in room air (i.e., off of supplemental oxygen) determined by verbal confirmation with child's caregiver and an (2) appropriate referral recommendation has been provided by the healthcare worker (HCW) according to WHO-defined hypoxaemia status (SpO2 <90% or >90%) as (3) determined by study staff measurement with reference device.
Day 1
Proportion of Children with Correct SpO2 management (definition 3)
Time Frame: Day 1
The proportion of children aged 0 to <24 months with acute respiratory infection and (1) a HCW-documented SpO2 and heart rate measured in room air (i.e., off of supplemental oxygen), and (2) an appropriate referral recommendation has been provided by the HCW according to WHO-defined hypoxaemia status (SpO2 <90% or >90%) and (3) SpO2 confirmed by study staff measurement with the device assigned to arm (within 2% SpO2 range above or below the documented SpO2).
Day 1
Proportion of Children with Correct SpO2 management (definition 4)
Time Frame: Day 1
The proportion of children aged 0 to <24 months with acute respiratory infection and (1) a SpO2 and heart rate measured in room air (i.e., off of supplemental oxygen) determined by verbal confirmation with child's caregiver and an (2) appropriate referral recommendation has been provided by the healthcare worker (HCW) according to WHO-defined hypoxaemia status (SpO2 <90% or >90%) as (3) determined by study staff measurement with the device assigned to arm.
Day 1
Proportion of Children with Correct SpO2 management (definition 5)
Time Frame: Day 1
The proportion of children aged 0 to <24 months with acute respiratory infection and (1) a HCW-documented SpO2 and heart rate measured in room air (i.e., off of supplemental oxygen), and (2) an appropriate referral recommendation has been provided by the HCW according to WHO-defined hypoxaemia status (SpO2 <90% or >90%) and (3) hypoxemia status confirmed by study staff measurement with reference device (either hypoxemic or not hypoxemic).
Day 1
Proportion of Children with Correct SpO2 management (definition 6)
Time Frame: Day 15 after enrollment
The proportion of children aged 0 to <24 months with acute respiratory infection and (1) a HCW-documented SpO2 and heart rate measured in room air (i.e., off of supplemental oxygen), and (2) an appropriate referral recommendation has been provided by the HCW according to WHO-defined hypoxaemia status (SpO2 <90% or >90%) and (3) hypoxemia status confirmed by study staff measurement with device assigned to arm (either hypoxemic or not hypoxemic).
Day 15 after enrollment
Communication fidelity as assessed by number of participants who had timely communication
Time Frame: Day 1
The timely communication between 1) clinic and referral hospital (on day 1), and 2) clinic and caregiver (on day 1)
Day 1
Proportion of plausible measurement (Quality measurement)
Time Frame: Day 1
Proportion of biologically plausible measurements among all measurements attempted by study staff and HCWs (only done when directly observed) using the assigned pulse oximeter device per arm and reference device.
Day 1
Feasibility as assessed by number of measurement attempts
Time Frame: Day 1
The number of measurement attempts required to achieve a biologically plausible SpO2 measurement by either study staff or HCWs (only done when directly observed)
Day 1
Measurement acceptance as assessed by the proportion of caregivers who permit Sp02 measurement
Time Frame: Day 1
The proportion of caregivers who permit the study staff or HCWs (only done when directly observed) to measure the SpO2 on the child.
Day 1
Referral acceptance as assessed by proportion of children who present to hospital
Time Frame: Day 2
Amongst WHO-defined hypoxemic children, the proportion of children who present to a hospital within 24 hours.
Day 2
Oxygen treatment as assessed by proportion of children who are given oxygen treatment
Time Frame: Day 2
Amongst WHO-defined hypoxemic children, the proportion who of children who present to a hospital and are given oxygen treatment within 24 hours.
Day 2
Treatment failure as assessed by proportion of children still feeling sick
Time Frame: Day 15
The proportion of enrolled children who reported still feeling sick or whose caregiver reported any of the following signs: cough at 14 days, difficult breathing at 14 days, or change in antibiotic treatment or re-admission to clinic/hospital anytime at or before two-weeks (14 days) post study enrollment as confirmed by phone or home visit.
Day 15
Hypoxemia prevalence
Time Frame: Day 1
Among all enrolled children who completed the intake/first (clinic) visit and had a successful SpO2 measurement, those whose (1) SpO2<90% (WHO-defined) as well as those (2) <94% (study defined) and (3) 90-93% (moderate), whose measurement was within -/+2% of the reference device measurement.
Day 1
Mortality
Time Frame: Day 15
Measured among all enrolled children who successfully completed two-week follow up and defined as the number of children who have died from any cause within 14 days of recruitment.
Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Karolinska Institutet
Baylor College of Medicine
Fogarty International Center of the National Institute of Health
University of Stellenbosch
Thrasher Research Fund

Investigators

  • Principal Investigator: Eric McCollum, MD, MPH, Johns Hopkins School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2024

Primary Completion (Actual)

April 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00444460
  • 4R33TW012212-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made available after publication of the primary analysis. Other researchers who submit a written request to the principal investigator with analysis plan, data sharing agreement, and institutional review board approval will be afforded access to individual participant data.

IPD Sharing Time Frame

Data will become available after publication of the primary analysis and will be available for at least 5 years.

IPD Sharing Access Criteria

Written request to the principal investigator, analysis plan, data sharing agreement, and institutional review board approval.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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