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Can Smartphone-Based oximeters save kids with pneumonia?

NCT ID NCT05914324

Knowledge-focused Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing two new types of pulse oximeters—simple devices that measure oxygen levels—for babies and toddlers with pneumonia in Cape Town, South Africa. Researchers want to see if these devices help healthcare workers correctly identify children with low oxygen and refer them for care. About 936 children under 2 years old will take part, and the goal is to improve pneumonia management in low-resource settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Phefumla device and LB-01 device (pulse oximeters)
What this could lead to
If successful, this could show that affordable, easy-to-use pulse oximeters help healthcare workers correctly identify and refer children with dangerously low oxygen levels, potentially reducing deaths from pneumonia in low-resource settings.
What could go wrong
This is an observational/device evaluation study, not a treatment trial. The devices may not perform as well as expected in real-world conditions, and results may not apply to other regions or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

936 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 23 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Hypoxia primary interstitial lung disease specific to childhood respiratory tract infectious disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Child Hypoxia Infant Respiratory tract infections

Contacts and locations

Locations

  • Desmond Tutu TB Centre

    Cape Town, Western Cape, 7505, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.