Bronchiolitis
Conditions
Keywords
infant, oxygen therapy, High flow nasal canula oxygen therapy, Bronchiolitis
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.
Interventions
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%.
DEVICELow-flow oxygen therapy with standard nasal canula
flow adjusted to SpO2 \> 94% (up to a maximum of 2l/min).
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Days to 6 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Oxgen-support free days | at the end of the follow up (an average of 7 days) | number of oxygen support free days |
| 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). |
Countries
France
Outcome results
None listed