NCT02856165

Brief Summary

Over the last decade, high-flow nasal oxygen therapy (HFN) has emerged as a new method to provide respiratory support in children with moderate to severe bronchiolitis. However, any randomized clinical trial (RCT) have demonstrated that earlier support with HFN is superior to standard care including low -flow nasal oxygen therapy to reduce the risk of acute respiratory failure requiring non invasive (or tracheal) ventilation and subsequently the need of PICU transfer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 28, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2017

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

July 19, 2016

Last Update Submit

April 27, 2018

Conditions

Bronchiolitis

Keywords

infantoxygen therapyHigh flow nasal canula oxygen therapyBronchiolitis

Outcome Measures

Primary Outcomes (1)

  • patient in treatment failure in each group (control or HFN) requiring non-invasive (or endotracheal) ventilation and ventilation-support free days

    Treatment failure is defined if one or more following criteria are met: refractory apnea (\> 3/h), oxygen requirement in HFN therapy arm exceeds fraction of inspired oxygen (FiO2) ≥ 40 % or oxygen requirement in standard nasal oxygen therapy arm exceeds \>2l/min to maintain oxygen saturation (SpO2) ≥94 %), m-WCAS score increased compared to admission at H6 and/or \> 5 , PaCO2 (H6 ) increased compared to admission and \> 60-70 mmHg.

    Up to an average of 7 days

Secondary Outcomes (5)

  • Transfer to pediatrics intensive care unit (PICU)

    at the end of the follow up (an average of 7 days)

  • Length of stay in paediatric general ward unit

    at the end of the follow up (an average of 7 days)

  • Oxgen-support free days

    at the end of the follow up (an average of 7 days)

  • Artificial nutritional-support free days

    at the end of the follow up (an average of 7 days)

  • Assessment of short term respiratory status

    at the end of the follow up (an average of 7 days)

Study Arms (2)

High-flow nasal canula oxygen therapy

EXPERIMENTAL

High-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (Fisher\&Paykel (F\&P), NZ)

Device: High-flow nasal canula oxygen therapy

Low-flow oxygen therapy

ACTIVE COMPARATOR

Low-flow oxygen therapy with standard nasal canula

Device: Low-flow oxygen therapy with standard nasal canula

Interventions

High-flow nasal canula oxygen therapyDEVICE

High-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (F\&P, NZ) at initial flow to 3l/kg/min (up to a maximum of 20l/min), FiO2 adjusted for SpO2 \> 94%.

Also known as: Optiflow
High-flow nasal canula oxygen therapy
Low-flow oxygen therapy with standard nasal canulaDEVICE

flow adjusted to SpO2 \> 94% (up to a maximum of 2l/min).

Also known as: Low-flow oxygen therapy
Low-flow oxygen therapy

Eligibility Criteria

Age7 Days - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • first episode of hospitalised bronchiolitis (as defined by American Academy of Pediatrics clinical criterions )
  • aged 7 days- 6 months
  • transcutaneous SpO2 in room air \< 95%
  • modified Wood's Clinical Asthma Score (m-WCAS) ≥ 2 et ≤ 5
  • agreement of at least one of the parents or legal tutor for his child to participate in biomedical research
  • affiliation to social security (beneficiary or entitled), except beneficiary of State medical help

You may not qualify if:

  • Urgent need for mechanical ventilation support either by nCPAP ou endotracheal route
  • Severe form defined by modified Wood's Clinical Asthma Score (mWCAS) exceeding 5 or 6, requiring non invasive ventilation (n CPAP)
  • Uncorrected cyanotic heart disease, innate immune deficiency, cranio-facial malformation, congenital stridor, tracheotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Philippe DURAND, MD

    AP-HP, Bicêtre Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

August 4, 2016

Study Start

October 28, 2016

Primary Completion

November 15, 2017

Study Completion

November 23, 2017

Last Updated

April 30, 2018

Record last verified: 2018-04

Locations

FR(1)