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NCT Number: NCT06715423

High Flow Nasal Oxygen Therapy an Implementation Study in Pediatric Wards

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.

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Key information

Conditions

Moderate Respiratory Distress Dyspnea Infections Lung Diseases Pathological Conditions, Signs and Symptoms Pneumonia Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Severe Respiratory Distress Signs and Symptoms Signs and Symptoms, Respiratory

Age range

1 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Recovery with SPO2 above 92%

    Time frame: From enrollment to day 3 to 10

Other outcomes

  1. Acceptability, feasibility and perception from the caretaker point of view

    Time frame: 2 weeks after hospitalisation

    interview of the caretaker

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

    Time frame: From Month 2 until Month 12

    Interview of the health staffs (doctors, nurses, biomed, managers, logisticians)

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabeth Poulet, MD, Msc

CONTACT

[email protected]

0033140215465

Sponsors and collaborators

Lead sponsor

Epicentre

Other

Collaborators

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

Registry information

Acronym: HFNO

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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