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

Bronchiolitis Clinical Trial

— BRONCHOPTI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856165
• Other study ID #: P150931
• Status: Completed
• Phase: N/A
• Start date: October 28, 2016
• Est. completion date: November 23, 2017

Study information

• Verified date: April 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: November 23, 2017
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

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%.
• Low-flow oxygen therapy with standard nasal canula
flow adjusted to SpO2 > 94% (up to a maximum of 2l/min).

Locations

Country	Name	City	State
France	AP-HP, Bicêtre Hospital	Le Kremlin Bicêtre

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Transfer to pediatrics intensive care unit (PICU)	Numbers of infants transferred to PICU in each arm	at the end of the follow up (an average of 7 days)
Secondary	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)	at the end of the follow up (an average of 7 days)
Secondary	Oxgen-support free days	number of oxygen support free days	at the end of the follow up (an average of 7 days)
Secondary	Artificial nutritional-support free 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)
Secondary	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).	at the end of the follow up (an average of 7 days)