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

Not Applicable

Completed

• Conditions: Bronchiolitis
• Interventions: Device: High-flow nasal canula oxygen therapy; Device: Low-flow oxygen therapy with standard nasal canula

• Registration Number: NCT02856165
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-31
• Study First Posted: 2016-08-04
• Study Start: 2016-10-28
• Primary Completion: 2017-11-15
• Study Completion: 2017-11-23
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-27
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-flow nasal canula oxygen therapy	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)
Low-flow oxygen therapy	Low-flow oxygen therapy with standard nasal canula	Low-flow oxygen therapy with standard nasal canula

Primary Outcome Measures

Name	Time	Method
patient in treatment failure in each group (control or HFN) requiring non-invasive (or endotracheal) ventilation and ventilation-support free days	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

Name	Time	Method
Transfer to pediatrics intensive care unit (PICU)	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	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)
Artificial nutritional-support free days	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	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).
Oxgen-support free days	at the end of the follow up (an average of 7 days)	number of oxygen support free days

Trial Locations

Locations (1)

AP-HP, Bicêtre Hospital; 🇫🇷 Le Kremlin Bicêtre, France