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Search / Trial NCT05914324

Outpatient Pediatric Pulse Oximeters in Africa

Launched by JOHNS HOPKINS UNIVERSITY · Jun 12, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, called "Outpatient Pediatric Pulse Oximeters in Africa," is studying how well three different pulse oximeters work for children with breathing problems in Cape Town, South Africa. The main goal is to find out if these devices can help doctors better manage children who have low oxygen levels, which can happen with respiratory infections. The trial includes two parts: one part will look at how effectively the new pulse oximeters help identify and treat low oxygen levels, while the other part will assess how common low oxygen levels are and the risks they pose to young children with these infections.

The trial is open to children from birth up to 24 months old who are showing signs of breathing difficulties, like coughing or trouble breathing. To participate, caregivers must agree to be contacted by the study team afterward and provide their contact information. If you join the study, your child will be monitored using these pulse oximeters during their outpatient visit, helping to improve future care for children with similar health issues. This study is important because it aims to improve how we manage children's health in settings where resources may be limited.

Gender

ALL

Eligibility 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

About Johns Hopkins University

Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.

Locations

Cape Town, Western Cape, South Africa

Patients applied

0 patients applied

Trial Officials

Eric McCollum, MD, MPH

Principal Investigator

Johns Hopkins School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported