Outpatient Pediatric Pulse Oximeters in Africa

NCT05914324 | Recruiting

• 2 other identifiers: IRB004444604R33TW012212-03
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 1

Secondary Outcomes (14)

• Proportion of Children with Correct SpO2 management (definition 2)

  Day 1

• Proportion of Children with Correct SpO2 management (definition 3)

  Day 1

• Proportion of Children with Correct SpO2 management (definition 4)

  Day 1

• Proportion of Children with Correct SpO2 management (definition 5)

  Day 1

• Proportion of Children with Correct SpO2 management (definition 6)

  Day 15 after enrollment

Study Arms (3)

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.

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.

Device: LB-01 device

Interventions

Phefumla device 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.

Phefumla

LB-01 device 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.

LB-01

Eligibility Criteria

• Age: 0 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Stellenbosch: collaborator
• Karolinska Institutet: collaborator
• Baylor College of Medicine: collaborator
• Fogarty International Center of the National Institute of Health: collaborator
• Thrasher Research Fund: collaborator

Study Sites (1)

Desmond Tutu TB Centre

Cape Town, Western Cape, 7505, South Africa

RECRUITING

Related Publications (11)

• 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.

  PMID: 34416195 BACKGROUND

• Reiner 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.

  PMID: 31570869 BACKGROUND

• WHO. World Health Organization Integrated Management of Childhood Illness ( IMCI ) Chart Booklet-Standard. Geneva (Switzerland): World Health Organization 2014; : 1-80.

  BACKGROUND

• 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.

  PMID: 26372640 BACKGROUND

• Rahman 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.

  PMID: 35180418 BACKGROUND

• McCollum 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.

  PMID: 27843130 BACKGROUND

• McCollum 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.

  PMID: 27994282 BACKGROUND

• King 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.

  PMID: 29382679 BACKGROUND

• Richards 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

• 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.

  PMID: 30984733 BACKGROUND

• Schuh 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.

  PMID: 41911473 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Hypoxia

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric McCollum, MD, MPH

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric D McCollum, MD MPH

CONTACT

+27790669233; emccoll3@jhmi.edu

Carina King, PhD

CONTACT

+46852480000; carina.king@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention the group who will be blinded are those conducting the analysis. PHC staff, caregivers/patients and study staff in facilities cannot be blinded to the allocation status. Researchers who are responsible for collecting data will be aware of the PHCs allocation. However, for other members of the research team, the investigators will separate those who have access to allocation and those who do not. The key of which PHCs are in which arm will be held by Stellenbosch, and the researcher who will conduct the primary analysis will not have access to this information until after the primary analysis has been completed and also approved by the Study Steering Committee (SSC). This is to ensure internal study integrity and validity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 22, 2023
• Study Start: November 4, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available after publication of the primary analysis and will be available for at least 5 years.
• Access Criteria: Written request to the principal investigator, analysis plan, data sharing agreement, and institutional review board approval.

Locations

ZA (1)