MedTrace Logo

Oxygen Therapy for Children With Moderate Hypoxemia in Malawi

NCT06176664 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-12-20

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Low flow oxygen

Standard nasal cannula oxygen up to 2 liters/minute

DEVICE

High-flow nasal cannula oxygen

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

Sponsors & Collaborators

Principal Investigators

  • Eric E McCollom, MD, MPH · Johns Hopkins School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2024-11-30
Completion
2024-11-30

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06176664 on ClinicalTrials.gov