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

April 27, 2018 updated by: Assistance Publique - Hôpitaux de Paris

High-flow Nasal Oxygen Therapy (Optiflow) in Hospitalized Infant With Moderate-to-severe Bronchiolitis: Multicentric Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Kremlin Bicêtre, France, 94270
        • AP-HP, Bicêtre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-flow nasal canula oxygen therapy
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
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%.
Other Names:
  • Optiflow
Active Comparator: Low-flow oxygen therapy
Low-flow oxygen therapy with standard nasal canula
Device: Low-flow oxygen therapy with standard nasal canula
flow adjusted to SpO2 > 94% (up to a maximum of 2l/min).
Other Names:
  • Low-flow oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient in treatment failure in each group (control or HFN) requiring non-invasive (or endotracheal) ventilation and ventilation-support free days
Time Frame: Up to an average of 7 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfer to pediatrics intensive care unit (PICU)
Time Frame: at the end of the follow up (an average of 7 days)
Numbers of infants transferred to PICU in each arm
at the end of the follow up (an average of 7 days)
Length of stay in paediatric general ward unit
Time Frame: at the end of the follow up (an average of 7 days)
number of days between the enrolment and return to home or the transfer to PICU when appropriate (treatment failure)
at the end of the follow up (an average of 7 days)
Oxgen-support free days
Time Frame: at the end of the follow up (an average of 7 days)
number of oxygen support free days
at the end of the follow up (an average of 7 days)
Artificial nutritional-support free days
Time Frame: at the end of the follow up (an average of 7 days)
number of artificial nutritional-support free days (enteral feeding or intravenous line)
at the end of the follow up (an average of 7 days)
Assessment of short term respiratory status
Time Frame: at the end of the follow up (an average of 7 days)
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).
at the end of the follow up (an average of 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Philippe DURAND, MD, AP-HP, Bicêtre Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2016

Primary Completion (Actual)

November 15, 2017

Study Completion (Actual)

November 23, 2017

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 31, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 27, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P150931

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bronchiolitis

Clinical Trials on High-flow nasal canula oxygen therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe