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

This study is currently recruiting participants.
Verified January 2017 by Assistance Publique - Hôpitaux de Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT02856165
First Posted: August 4, 2016
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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.


Condition Intervention
Bronchiolitis Device: High-flow nasal canula oxygen therapy Device: Low-flow oxygen therapy with standard nasal canula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: High-flow Nasal Oxygen Therapy (Optiflow) in Hospitalized Infant With Moderate-to-severe Bronchiolitis: Multicentric Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

  • 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)

  • Oxgen-support free days [ Time Frame: at the end of the follow up (an average of 7 days) ]
    number of oxygen support free 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)

  • 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).


Estimated Enrollment: 276
Study Start Date: October 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Low-flow oxygen therapy

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856165


Contacts
Contact: Philippe DURAND, MD 00 33 1 45 21 72 25 philippe.durand2@aphp.fr
Contact: Vincent GAJDOS, MD, PhD vincent.gajdos@aphp.fr

Locations
France
AP-HP, Bicêtre Hospital Recruiting
Le Kremlin Bicêtre, France, 94270
Contact: Irina CRAIU, MD    00 33 1 45 21 31 44    irina.craiu@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Philippe DURAND, MD AP-HP, Bicêtre Hospital
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02856165     History of Changes
Other Study ID Numbers: P150931
First Submitted: July 19, 2016
First Posted: August 4, 2016
Last Update Posted: March 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Assistance Publique - Hôpitaux de Paris:
infant
oxygen therapy
High flow nasal canula oxygen therapy
Bronchiolitis

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections