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Not yet recruitingNCT06715423HFNOUpdated Jan 30, 2025

High Flow Nasal Oxygen Therapy an Implementation Study in Pediatric Wards

An observational study in Moderate Respiratory Distress and Severe Respiratory Distress, sponsored by Epicentre. Not yet recruiting at 1 site in Afghanistan. Open to participants aged 1 Month to 5 Years. Per ClinicalTrials.gov, last updated 2025-01-30.

Sponsored by Epicentre · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
960
Ages
1 Month to 5 Years
Sex
All
01

Study 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.

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

02

Conditions studied

  • Moderate Respiratory Distress
  • Severe Respiratory Distress

Keywords

  • oxygen
  • high flow
  • pneumonia
  • pediatrics
03

In context

Dyspnea

894 studies on the registry are indexed under Dyspnea; 189 are open to participants now.

This study's planned enrollment of 960 is above the median of 106 across 272 observational studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

Epicentre is the lead sponsor of 49 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 5 Years
Sexes eligible
All
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)

Eligibility criteria

Inclusion Criteria:

  • prescription of HFNO by clinician
  • parent consenting to the use of the data
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
960 participants (estimated)
Target follow-up
2 Weeks
Patient registry
Yes

Groups and cohorts

  • Pediactric ICU Hospitalized children 1mo to 5 yo

    Prescription of HFNO therapy

06

What researchers measure

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

    interview of the caretaker

    Time frame: 2 weeks after hospitalisation

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

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

    Time frame: From Month 2 until Month 12

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — Based on the data sharing policy of MSF

Supporting information: Clinical study report

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2025; primary completion for Dec 2025, 11 months later.

Of 116 non-industry observational studies under Dyspnea, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 11 months is below that.

Counting every sponsor, half of 125 studies reached it within 24 months; a quarter within 11 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2024
First posted
Dec 4, 2024
StartEst.
Jan 2025
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Jan 30, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06715423
Lead sponsor
Epicentre
Collaborators
MOH Afghanistan, MOH Bangladesh, MOH Sierra Leone, MOH Yemen, MSF Médecins Sans Frontières Belgium, MSF Médecins Sans Frontières France, Fisher and Paykel Healthcare
Responsible party
Sponsor
First posted
Dec 4, 2024
Start date
Jan 2025 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Jan 30, 2025

Study contacts

Elisabeth Poulet, MD, Msc
Contact
elisabeth.poulet@epicentre.msf.org
0033140215465

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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