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

NCT ID: NCT02856165

Last Updated: 2018-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-28
• Study Completion Date: 2017-11-23

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

High-flow nasal canula oxygen therapy

Intervention Type: 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%.

Low-flow oxygen therapy

Low-flow oxygen therapy with standard nasal canula

Group Type: ACTIVE_COMPARATOR

Low-flow oxygen therapy with standard nasal canula

Intervention Type: DEVICE

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

Interventions

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%.

Intervention Type: DEVICE

Low-flow oxygen therapy with standard nasal canula

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

Intervention Type: DEVICE

Other Intervention Names

Optiflow; Low-flow oxygen therapy

Eligibility 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.

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe DURAND, MD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Bicêtre Hospital

Locations

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, , France

Countries

France

Other Identifiers

P150931

Identifier Type: -

Identifier Source: org_study_id