Moderate Respiratory DistressHFNONCT06715423
High Flow Nasal Oxygen Therapy an Implementation Study in Pediatric Wards
An observational study of Moderate Respiratory Distress and Severe Respiratory Distress, run by Epicentre at 1 site in Afghanistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Moderate Respiratory Distress, Severe Respiratory Distress
- How many people
- 960 participants
- Where
- 1 siteAfghanistan
- Study dates
- Jan 2025to Dec 2025
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: MSF pediatric ICU in 4 sites (Herat- Afghanistan, Kenema- Sierra Leone, Goyalmara hospital for Rohingya refugee - Bangladesh, Khamir- Yemen)
Who may be able to join
- prescription of HFNO by clinician
- parent consenting to the use of the data
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Afghanistan1 site
Herat regional Hospital
Herat
Hamayoun Hemat, MD, 0093782174114, Msf-afghanistan-medcopdep@msf.org
About this study
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.
Read the detailed description
Mixed method study: quantitative component for the data of the children and qualitative data for the perception for health staffs and parents
- Keywords
- oxygen, high flow, pneumonia, pediatrics
- Medical subject headings
- Dyspnea, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediactric ICU Hospitalized children 1mo to 5 yo | Prescription of HFNO therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery with SPO2 above 92%
Measured: From enrollment to day 3 to 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Respiratory DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 960 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- MOH Afghanistan, MOH Bangladesh, MOH Sierra Leone, MOH Yemen, Médecins Sans Frontières, Belgium, Médecins Sans Frontières, France, Fisher and Paykel Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715423
- Sponsor's protocol ID
- G2429-HFNO_ProcessEvaluation
- Acronym
- HFNO
- Status last verified
- Jan 2025
- First submitted
- 26 Nov 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Based on the data sharing policy of MSF
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Oxygen Therapy an Implementation Study in Pediatric Wards
- ClinicalTrials.gov ID
- NCT06715423
- Acronym / sponsor ID
- HFNO / G2429-HFNO_ProcessEvaluation
- Keywords
- oxygen, high flow, pneumonia, pediatrics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- MOH Afghanistan, MOH Bangladesh, MOH Sierra Leone, MOH Yemen, Médecins Sans Frontières, Belgium, Médecins Sans Frontières, France, Fisher and Paykel Healthcare
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediactric ICU Hospitalized children 1mo to 5 yo | – | –Prescription of HFNO therapy |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- MSF pediatric ICU in 4 sites (Herat- Afghanistan, Kenema- Sierra Leone, Goyalmara hospital for Rohingya refugee - Bangladesh, Khamir- Yemen)
Key inclusion criteria (2 listed)
- prescription of HFNO by clinician
- parent consenting to the use of the data
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recovery with SPO2 above 92%
Time frame: From enrollment to day 3 to 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: Yes. Based on the data sharing policy of MSF
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate Respiratory Distress and Severe Respiratory Distress, run by Epicentre at 1 site in Afghanistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Afghanistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Poulet, MD, Msc (0033140215465, elisabeth.poulet@epicentre.msf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery with SPO2 above 92% (time frame: From enrollment to day 3 to 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.