Evaluating pulse oximeters for children in Cape Town
Evaluating Novel Pediatric Pulse Oximeters for Outpatient Child Pneumonia Care in Sub-Saharan Africa
This study is testing two new pulse oximeter devices to see if they can help doctors better manage low oxygen levels in children with respiratory infections in Cape Town.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 0 Months to 23 Months |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Cape Town, Western Cape) |
| Trial ID | NCT05914324 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of two novel pediatric pulse oximeter devices in managing hypoxemia among children with respiratory infections in Cape Town, South Africa. The study will involve two main objectives: first, to determine how these devices impact the management of hypoxemia, and second, to analyze the burden of hypoxemia and associated mortality risks in children presenting with acute respiratory infections. By generating evidence on the use of pulse oximetry in outpatient care, the trial seeks to address critical gaps in the management of lower respiratory tract infections in low-resource settings.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 24 months who present with acute respiratory conditions characterized by cough or difficulty breathing.
Not a fit: Patients older than 24 months or those presenting with non-acute conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the early identification and management of hypoxemia in children, potentially reducing mortality rates associated with respiratory infections.
How similar studies have performed: Other studies have shown promise in using pulse oximetry to improve outcomes in similar low-resource settings, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cape Town, Western Cape
- Desmond Tutu TB Centre — Cape Town, Western Cape, South Africa (Recruiting)
Study contacts
- Principal investigator: Eric McCollum, MD, MPH — Johns Hopkins School of Medicine
- Study coordinator: Eric D McCollum, MD MPH
- Email: emccoll3@jhmi.edu
- Phone: +27790669233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.