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Completed

NCT Number: NCT02856165

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

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.

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

7 day–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94270, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-flow nasal canula oxygen therapy

Device

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

Low-flow oxygen therapy with standard nasal canula

Device

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

Other names: Low-flow oxygen therapy

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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)

  3. Oxgen-support free days

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

    number of oxygen support free days

  4. 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)

  5. 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).

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

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

Registry information

Official study title

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

Acronym: BRONCHOPTI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2016
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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