High Flow Nasal Oxygen Therapy an Implementation Study in... | NCT06715423

Studies
High Flow Nasal Oxygen Therapy an Implementation Study in Pediatric Wards

NCT06715423

Sponsor

Epicentre

Status

Not yet recruiting

Last Update Posted

Jan 30, 2025Actual

Enrollment

960Estimated

Phase

Not provided

Conditions

Moderate Respiratory Distress
Severe Respiratory Distress

Interventions

Not provided

Countries

Afghanistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2025Estimated

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Nov 26, 2024

First Submission Date that Met QC Criteria

Nov 28, 2024

First Posted Date

Dec 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2025

Last Update Posted Date

Jan 30, 2025Actual

Name	Class
MOH Afghanistan	UNKNOWN
MOH Bangladesh	UNKNOWN
MOH Sierra Leone	UNKNOWN
MOH Yemen

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

960Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pediactric ICU Hospitalized children 1mo to 5 yo		Prescription of HFNO therapy

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

5 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elisabeth Poulet, MD, Msc	Contact	0033140215465		elisabeth.poulet@epicentre.msf.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herat regional Hospital		Herat			Afghanistan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Based on the data sharing policy of MSF

Types

Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004417	Dyspnea
D011014	Pneumonia

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided