CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Low flow oxygen +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06176664
NCT06176664N/ACompleted
CompareCT.gov

Oxygen Therapy for Children With Moderate Hypoxemia in Malawi: Pilot Randomized Control Trial

Johns Hopkins University·interventional·Posted Dec 20, 2023·Updated Dec 20, 2024

In Brief

A clinical study evaluating Low flow oxygen and High-flow nasal cannula oxygen for Pneumonia. Completed, enrolled 21 participants across 1 site.

Detailed Summary

The goal of this pilot clinical trial is to compare standard of care, low-flow oxygen, and high-flow nasal canula oxygen in pediatric patients aged 1-59 months with pneumonia and an oxygen saturation of 90-93% in Malawi. The main question it aims to answer is: * Does the protocol for the randomized control trial work well? * Can the researchers safely conduct the protocol for the trial? Participants will be randomly assigned to one of the three groups (normal care without oxygen, low-flow oxygen, and high-flow nasal cannula oxygen) and treated with that therapy in the hospital. Researchers will look at the ability to safely conduct each part of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia
CountriesMalawi
CollaboratorsThrasher Research Fund

Timeline

N/ACompletedFinished
202420252026
First PostedDec 20, 2023
Enrollment StartMay 15, 2024
Primary CompletionNov 30, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.5 years ago

Interventions

Low flow oxygendevice

Standard nasal cannula oxygen up to 2 liters/minute

High-flow nasal cannula oxygendevice

High-flow nasal cannula with heating and humidification up to 2 liters/kilogram/minute