High Flow Nasal Oxygen Therapy an Implementation Study in Pediatric Wards (HFNO)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Moderate Respiratory Distress; Severe Respiratory Distress

Detailed Description

Mixed method study: quantitative component for the data of the children and qualitative data for the perception for health staffs and parents

• Study Type: Observational
• Enrollment (Estimated): 960

Contacts and Locations

• Study Contact: Name: Elisabeth Poulet, MD, Msc; Phone Number: 0033140215465; Email: elisabeth.poulet@epicentre.msf.org

Study Locations

• Afghanistan
  • Herat, Afghanistan
    • Herat regional Hospital
    • Contact: Hamayoun Hemat, MD; Phone Number: 0093782174114; Email: Msf-afghanistan-medcopdep@msf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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)

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pediactric ICU Hospitalized children 1mo to 5 yo; Prescription of HFNO therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recovery with SPO2 above 92%	From enrollment to day 3 to 10

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability, feasibility and perception from the caretaker point of view	interview of the caretaker	2 weeks after hospitalisation
Acceptability, feasibility and perception from the health staff point of view	Interview of the health staffs (doctors, nurses, biomed, managers, logisticians)	From Month 2 until Month 12

Collaborators and Investigators

• Sponsor: Epicentre
• Collaborators: Fisher and Paykel Healthcare; MOH Afghanistan; MOH Bangladesh; MOH Sierra Leone; MOH Yemen; MSF Médecins Sans Frontières Belgium; MSF Médecins Sans Frontières France

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: pediatrics; pneumonia; oxygen; high flow
• Other Study ID Numbers: G2429-HFNO_ProcessEvaluation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Based on the data sharing policy of MSF
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No