ChildNCT05914324
Outpatient Pediatric Pulse Oximeters in Africa
A study testing Phefumla device and LB-01 device in people with Child and Infant, run by Johns Hopkins University at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 23 months
- Conditions the study is for
- Child, Infant, Respiratory Tract Infections
- What is being tested?
- Phefumla device and LB-01 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 936 participants
- Where
- 1 siteSouth Africa
- Study dates
- 4 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Child, Infant, Respiratory Tract Infections, Hypoxia
- Being tested
- Phefumla device, LB-01 device
- Medical subject headings
- Respiratory Tract Infections, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phefumla deviceDevice
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.
LB-01 deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Controls | No intervention | 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. |
| Phefumla | Experimental | 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. Receives: Device: Phefumla device |
| LB-01 | Experimental | 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. Receives: Device: LB-01 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Children with Correct management of oxygen saturation
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).
Measured: Day 1
Secondary outcomes (14)
Proportion of Children with Correct SpO2 management (definition 2)
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.
Measured: Day 1
Proportion of Children with Correct SpO2 management (definition 3)
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).
Measured: Day 1
Proportion of Children with Correct SpO2 management (definition 4)
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.
Measured: Day 1
Proportion of Children with Correct SpO2 management (definition 5)
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).
Measured: Day 1
Proportion of Children with Correct SpO2 management (definition 6)
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).
Measured: Day 15 after enrollment
Communication fidelity as assessed by number of participants who had timely communication
The timely communication between 1) clinic and referral hospital (on day 1), and 2) clinic and caregiver (on day 1)
Measured: Day 1
Proportion of plausible measurement (Quality measurement)
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.
Measured: Day 1
Feasibility as assessed by number of measurement attempts
The number of measurement attempts required to achieve a biologically plausible SpO2 measurement by either study staff or HCWs (only done when directly observed)
Measured: Day 1
Measurement acceptance as assessed by the proportion of caregivers who permit Sp02 measurement
The proportion of caregivers who permit the study staff or HCWs (only done when directly observed) to measure the SpO2 on the child.
Measured: Day 1
Referral acceptance as assessed by proportion of children who present to hospital
Amongst WHO-defined hypoxemic children, the proportion of children who present to a hospital within 24 hours.
Measured: Day 2
Oxygen treatment as assessed by proportion of children who are given oxygen treatment
Amongst WHO-defined hypoxemic children, the proportion who of children who present to a hospital and are given oxygen treatment within 24 hours.
Measured: Day 2
Treatment failure as assessed by proportion of children still feeling sick
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.
Measured: Day 15
Hypoxemia prevalence
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.
Measured: Day 1
Mortality
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.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start4 Nov 2024
- Primary completion30 Apr 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for ChildStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic 3-arm cluster randomised controlled trial (cRCT), conducted over a 18-month period. Clusters are defined as outpatient facilities (PHC, CDC, CHC), and the primary and secondary child-level outcomes will be assessed through a prospective cohort study. An embedded mixed-methods concurrent process evaluation will be conducted.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 936 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stellenbosch, Karolinska Institutet, Baylor College of Medicine, Fogarty International Center of the National Institute of Health, Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Eric McCollum, MD, MPH, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914324
- Sponsor's protocol ID
- IRB00444460
- Other IDs
- 4R33TW012212-03
- Status last verified
- May 2026
- First submitted
- 1 Jun 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
GBD 2019 Under-5 Mortality Collaborators. Global, regional, and national progress towards Sustainable Development Goal 3.2 for neonatal and child health: all-cause and cause-specific mortality findings from the Global Burden of Disease Study 2019. Lancet. 2021 Sep 4;398(10303):870-905. doi: 10.1016/S0140-6736(21)01207-1. Epub 2021 Aug 17.
PubMed 34416195Reiner RC, Welgan CA, Casey DC, Troeger CE, Baumann MM, Nguyen QP, Swartz SJ, Blacker BF, Deshpande A, Mosser JF, Osgood-Zimmerman AE, Earl L, Marczak LB, Munro SB, Miller-Petrie MK, Rodgers Kemp G, Frostad J, Wiens KE, Lindstedt PA, Pigott DM, Dwyer-Lindgren L, Ross JM, Burstein R, Graetz N, Rao PC, Khalil IA, Davis Weaver N, Ray SE, Davis I, Farag T, Brady OJ, Kraemer MUG, Smith DL, Bhatt S, Weiss DJ, Gething PW, Kassebaum NJ, Mokdad AH, Murray CJL, Hay SI. Identifying residual hotspots and mapping lower respiratory infection morbidity and mortality in African children from 2000 to 2017. Nat Microbiol. 2019 Dec;4(12):2310-2318. doi: 10.1038/s41564-019-0562-y. Epub 2019 Sep 30.
PubMed 31570869WHO. World Health Organization Integrated Management of Childhood Illness ( IMCI ) Chart Booklet-Standard. Geneva (Switzerland): World Health Organization 2014; : 1-80.
Lazzerini M, Sonego M, Pellegrin MC. Hypoxaemia as a Mortality Risk Factor in Acute Lower Respiratory Infections in Children in Low and Middle-Income Countries: Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 15;10(9):e0136166. doi: 10.1371/journal.pone.0136166. eCollection 2015.
PubMed 26372640Rahman AE, Hossain AT, Nair H, Chisti MJ, Dockrell D, Arifeen SE, Campbell H. Prevalence of hypoxaemia in children with pneumonia in low-income and middle-income countries: a systematic review and meta-analysis. Lancet Glob Health. 2022 Mar;10(3):e348-e359. doi: 10.1016/S2214-109X(21)00586-6.
PubMed 35180418McCollum ED, King C, Hammitt LL, Ginsburg AS, Colbourn T, Baqui AH, O'Brien KL. Reduction of childhood pneumonia mortality in the Sustainable Development era. Lancet Respir Med. 2016 Dec;4(12):932-933. doi: 10.1016/S2213-2600(16)30371-X. Epub 2016 Nov 12. No abstract available.
PubMed 27843130McCollum ED, King C, Deula R, Zadutsa B, Mankhambo L, Nambiar B, Makwenda C, Masache G, Lufesi N, Mwansambo C, Costello A, Colbourn T. Pulse oximetry for children with pneumonia treated as outpatients in rural Malawi. Bull World Health Organ. 2016 Dec 1;94(12):893-902. doi: 10.2471/BLT.16.173401. Epub 2016 Oct 11.
PubMed 27994282King C, Boyd N, Walker I, Zadutsa B, Baqui AH, Ahmed S, Islam M, Kainja E, Nambiar B, Wilson I, McCollum ED. Opportunities and barriers in paediatric pulse oximetry for pneumonia in low-resource clinical settings: a qualitative evaluation from Malawi and Bangladesh. BMJ Open. 2018 Jan 30;8(1):e019177. doi: 10.1136/bmjopen-2017-019177.
PubMed 29382679Richards D, Hunter L, Forey K, et al. Demographics and predictors of mortality in children undergoing resuscitation at Khayelitsha Hospital, Western Cape, South Africa. SAJCH South African Journal of Child Health 2018; 12: 127-31
Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.
PubMed 30984733Schuh HB, Van der Zalm M, Van Niekerk M, Laubscher LM, Mcinziba A, Gomas S, Kapoor S, Hooli S, Viljoen L, Gie A, Nonyane BAS, Goussard P, Hesseling AC, King C, McCollum ED. Clinical Evaluation of Pediatric Pulse Oximeters in South Africa: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2026 Mar 30;15:e82888. doi: 10.2196/82888.
PubMed 41911473
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Novel Pediatric Pulse Oximeters for Outpatient Child Pneumonia Care in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT05914324
- Acronym / sponsor ID
- IRB00444460
- Conditions
- Child, Infant, Respiratory Tract Infections, Hypoxia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 936 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Stellenbosch, Karolinska Institutet, Baylor College of Medicine, Fogarty International Center of the National Institute of Health, Thrasher Research Fund
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Pragmatic 3-arm cluster randomised controlled trial (cRCT), conducted over a 18-month period. Clusters are defined as outpatient facilities (PHC, CDC, CHC), and the primary and secondary child-level outcomes will be assessed through a prospective cohort study. An embedded mixed-methods concurrent process evaluation will be conducted.
| Arm | Type | Receives |
|---|---|---|
| Controls | No intervention | –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. |
| Phefumla | Experimental | Device: Phefumla devicePhefumla 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. |
| LB-01 | Experimental | Device: LB-01 deviceLB-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. |
Who may qualify
- Ages
- 0 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phefumla deviceThe 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 | Phefumla |
| LB-01 deviceThe 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. | Device | LB-01 |
Primary outcome
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).
14 secondary outcomes
Proportion of Children with Correct SpO2 management (definition 2)
Time frame: Day 1
Proportion of Children with Correct SpO2 management (definition 3)
Time frame: Day 1
Proportion of Children with Correct SpO2 management (definition 4)
Time frame: Day 1
Proportion of Children with Correct SpO2 management (definition 5)
Time frame: Day 1
Proportion of Children with Correct SpO2 management (definition 6)
Time frame: Day 15 after enrollment
Communication fidelity as assessed by number of participants who had timely communication
Time frame: Day 1
Proportion of plausible measurement (Quality measurement)
Time frame: Day 1
Feasibility as assessed by number of measurement attempts
Time frame: Day 1
Measurement acceptance as assessed by the proportion of caregivers who permit Sp02 measurement
Time frame: Day 1
Referral acceptance as assessed by proportion of children who present to hospital
Time frame: Day 2
Oxygen treatment as assessed by proportion of children who are given oxygen treatment
Time frame: Day 2
Treatment failure as assessed by proportion of children still feeling sick
Time frame: Day 15
Hypoxemia prevalence
Time frame: Day 1
Mortality
Time frame: Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 34416195GBD 2019 Under-5 Mortality Collaborators. Global, regional, and national progress towards Sustainable Development Goal 3.2 for neonatal and child health: all-cause and cause-specific mortality findings from the Global Burden of Disease Study 2019. Lancet. 2021 Sep 4;398(10303):870-905. doi: 10.1016/S0140-6736(21)01207-1. Epub 2021 Aug 17.
- Background: PubMed 31570869Reiner RC, Welgan CA, Casey DC, Troeger CE, Baumann MM, Nguyen QP, Swartz SJ, Blacker BF, Deshpande A, Mosser JF, Osgood-Zimmerman AE, Earl L, Marczak LB, Munro SB, Miller-Petrie MK, Rodgers Kemp G, Frostad J, Wiens KE, Lindstedt PA, Pigott DM, Dwyer-Lindgren L, Ross JM, Burstein R, Graetz N, Rao PC, Khalil IA, Davis Weaver N, Ray SE, Davis I, Farag T, Brady OJ, Kraemer MUG, Smith DL, Bhatt S, Weiss DJ, Gething PW, Kassebaum NJ, Mokdad AH, Murray CJL, Hay SI. Identifying residual hotspots and mapping lower respiratory infection morbidity and mortality in African children from 2000 to 2017. Nat Microbiol. 2019 Dec;4(12):2310-2318. doi: 10.1038/s41564-019-0562-y. Epub 2019 Sep 30.
- BackgroundWHO. World Health Organization Integrated Management of Childhood Illness ( IMCI ) Chart Booklet-Standard. Geneva (Switzerland): World Health Organization 2014; : 1-80.
- Background: PubMed 26372640Lazzerini M, Sonego M, Pellegrin MC. Hypoxaemia as a Mortality Risk Factor in Acute Lower Respiratory Infections in Children in Low and Middle-Income Countries: Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 15;10(9):e0136166. doi: 10.1371/journal.pone.0136166. eCollection 2015.
- Background: PubMed 35180418Rahman AE, Hossain AT, Nair H, Chisti MJ, Dockrell D, Arifeen SE, Campbell H. Prevalence of hypoxaemia in children with pneumonia in low-income and middle-income countries: a systematic review and meta-analysis. Lancet Glob Health. 2022 Mar;10(3):e348-e359. doi: 10.1016/S2214-109X(21)00586-6.
- Background: PubMed 27843130McCollum ED, King C, Hammitt LL, Ginsburg AS, Colbourn T, Baqui AH, O'Brien KL. Reduction of childhood pneumonia mortality in the Sustainable Development era. Lancet Respir Med. 2016 Dec;4(12):932-933. doi: 10.1016/S2213-2600(16)30371-X. Epub 2016 Nov 12. No abstract available.
- Background: PubMed 27994282McCollum ED, King C, Deula R, Zadutsa B, Mankhambo L, Nambiar B, Makwenda C, Masache G, Lufesi N, Mwansambo C, Costello A, Colbourn T. Pulse oximetry for children with pneumonia treated as outpatients in rural Malawi. Bull World Health Organ. 2016 Dec 1;94(12):893-902. doi: 10.2471/BLT.16.173401. Epub 2016 Oct 11.
- Background: PubMed 29382679King C, Boyd N, Walker I, Zadutsa B, Baqui AH, Ahmed S, Islam M, Kainja E, Nambiar B, Wilson I, McCollum ED. Opportunities and barriers in paediatric pulse oximetry for pneumonia in low-resource clinical settings: a qualitative evaluation from Malawi and Bangladesh. BMJ Open. 2018 Jan 30;8(1):e019177. doi: 10.1136/bmjopen-2017-019177.
- BackgroundRichards D, Hunter L, Forey K, et al. Demographics and predictors of mortality in children undergoing resuscitation at Khayelitsha Hospital, Western Cape, South Africa. SAJCH South African Journal of Child Health 2018; 12: 127-31
- Background: PubMed 30984733Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.
- Derived from this study: PubMed 41911473Schuh HB, Van der Zalm M, Van Niekerk M, Laubscher LM, Mcinziba A, Gomas S, Kapoor S, Hooli S, Viljoen L, Gie A, Nonyane BAS, Goussard P, Hesseling AC, King C, McCollum ED. Clinical Evaluation of Pediatric Pulse Oximeters in South Africa: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2026 Mar 30;15:e82888. doi: 10.2196/82888.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Child
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric McCollum, MD, MPH principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phefumla device and LB-01 device in people with Child and Infant, run by Johns Hopkins University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Children with Correct management of oxygen saturation (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05914324, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.