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High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis (BRONCHOPTI)

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High-flow nasal canula oxygen therapy
Low-flow oxygen therapy with standard nasal canula
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bronchiolitis focused on measuring infant, oxygen therapy, High flow nasal canula oxygen therapy, Bronchiolitis

Eligibility Criteria

7 Days - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Inclusion in other observational study.

Sites / Locations

  • AP-HP, Bicêtre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-flow nasal canula oxygen therapy

Low-flow oxygen therapy

Arm Description

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

Low-flow oxygen therapy with standard nasal canula

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Transfer to pediatrics intensive care unit (PICU)
Numbers of infants transferred to PICU in each arm
Length of stay in paediatric general ward unit
number of days between the enrolment and return to home or the transfer to PICU when appropriate (treatment failure)
Oxgen-support free days
number of oxygen support free days
Artificial nutritional-support free days
number of artificial nutritional-support free days (enteral feeding or intravenous line)
Assessment of short term respiratory status
Sequential assessment of short term (H1, 6, 12, 24) respiratory status including respiratory rate, heart-rate, SpO2, m-WCAS score, transcutaneous carbon dioxide partial pressure (tcPaCO2).

Full Information

First Posted
July 19, 2016
Last Updated
April 27, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02856165
Brief Title
High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis
Acronym
BRONCHOPTI
Official Title
High-flow Nasal Oxygen Therapy (Optiflow) in Hospitalized Infant With Moderate-to-severe Bronchiolitis: Multicentric Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 28, 2016 (Actual)
Primary Completion Date
November 15, 2017 (Actual)
Study Completion Date
November 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Open label, non-blinded multi-centre, randomised controlled trial comparing standard care including oxygen delivery via HFN versus standard nasal oxygen therapy in infants admitted to hospital with moderate-to-severe bronchiolitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
infant, oxygen therapy, High flow nasal canula oxygen therapy, Bronchiolitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-flow nasal canula oxygen therapy
Arm Type
Experimental
Arm Description
High-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (Fisher&Paykel (F&P), NZ)
Arm Title
Low-flow oxygen therapy
Arm Type
Active Comparator
Arm Description
Low-flow oxygen therapy with standard nasal canula
Intervention Type
Device
Intervention Name(s)
High-flow nasal canula oxygen therapy
Other Intervention Name(s)
Optiflow
Intervention Description
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%.
Intervention Type
Device
Intervention Name(s)
Low-flow oxygen therapy with standard nasal canula
Other Intervention Name(s)
Low-flow oxygen therapy
Intervention Description
flow adjusted to SpO2 > 94% (up to a maximum of 2l/min).
Primary Outcome Measure Information:
Title
patient in treatment failure in each group (control or HFN) requiring non-invasive (or endotracheal) ventilation and ventilation-support free days
Description
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.
Time Frame
Up to an average of 7 days
Secondary Outcome Measure Information:
Title
Transfer to pediatrics intensive care unit (PICU)
Description
Numbers of infants transferred to PICU in each arm
Time Frame
at the end of the follow up (an average of 7 days)
Title
Length of stay in paediatric general ward unit
Description
number of days between the enrolment and return to home or the transfer to PICU when appropriate (treatment failure)
Time Frame
at the end of the follow up (an average of 7 days)
Title
Oxgen-support free days
Description
number of oxygen support free days
Time Frame
at the end of the follow up (an average of 7 days)
Title
Artificial nutritional-support free days
Description
number of artificial nutritional-support free days (enteral feeding or intravenous line)
Time Frame
at the end of the follow up (an average of 7 days)
Title
Assessment of short term respiratory status
Description
Sequential assessment of short term (H1, 6, 12, 24) respiratory status including respiratory rate, heart-rate, SpO2, m-WCAS score, transcutaneous carbon dioxide partial pressure (tcPaCO2).
Time Frame
at the end of the follow up (an average of 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Inclusion in other observational study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe DURAND, MD
Organizational Affiliation
AP-HP, Bicêtre Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AP-HP, Bicêtre Hospital
City
Le Kremlin Bicêtre
ZIP/Postal Code
94270
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis

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