High Flow Nasal Oxygen Therapy an Implementation Study in Pediatric Wards

NCT06715423 | Not Yet Recruiting

• 1 other identifier: G2429-HFNO_ProcessEvaluation
• Study Type: observational
• Target: 960
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to prospectively evaluate the process of implementing HFNO in several MSF projects, varying according to geographical and programmatic contexts, population, health structures, human resources, and management. It will generate evidence on the operational feasibility (in terms of human resources, equipment, logistics and costs) of integrating HFNO into PICU standard of care, as well as on the users' and caregivers' perspectives on HFNO and on the children clinical outcomes observed where HFNO is implemented. This relevant information will guide MSF in the decision making of scaling up HFNO therapy in its projects.

Conditions

Moderate Respiratory Distress; Severe Respiratory Distress

Keywords

oxygen; high flow; pneumonia; pediatrics

Outcome Measures

Primary Outcomes (1)

• Recovery with SPO2 above 92%

  From enrollment to day 3 to 10

Other Outcomes (2)

• Acceptability, feasibility and perception from the caretaker point of view

  2 weeks after hospitalisation

• Acceptability, feasibility and perception from the health staff point of view

  From Month 2 until Month 12

Study Arms (1)

Pediactric ICU Hospitalized children 1mo to 5 yo

Prescription of HFNO therapy

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

MSF pediatric ICU in 4 sites (Herat- Afghanistan, Kenema- Sierra Leone, Goyalmara hospital for Rohingya refugee - Bangladesh, Khamir- Yemen)

You may qualify if:

• prescription of HFNO by clinician
• parent consenting to the use of the data

Sponsors & Collaborators

• Epicentre: lead
• MOH Afghanistan: collaborator
• MOH Bangladesh: collaborator
• MOH Sierra Leone: collaborator
• MOH Yemen: collaborator
• MSF Médecins Sans Frontières Belgium: collaborator
• MSF Médecins Sans Frontières France: collaborator
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Herat regional Hospital

Herat, Afghanistan

Location

MeSH Terms

Conditions

Dyspnea; Pneumonia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Lung Diseases

Central Study Contacts

Elisabeth Poulet, MD, Msc

CONTACT

0033140215465; elisabeth.poulet@epicentre.msf.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 4, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

AF (1)