Outpatient Pediatric Pulse Oximeters in Africa (NCT05914324) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Outpatient Pediatric Pulse Oximeters in Africa
South Africa936 participantsStarted 2024-11-04
Plain-language 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.
Who can participate
Age range
0 Months – 23 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Children with Correct management of oxygen saturation