TY - JOUR
T1 - Efficacy and safety of exogenous surfactant therapy in patients under 12 months of age invasively ventilated for severe bronchiolitis (SURFABRON): Protocol for a multicentre, randomised, double-blind, controlled, non-profit trial
AU - Biban, P.
AU - Conti, G.
AU - Wolfler, A.M.
AU - Carlassara, S.
AU - Gitto, E.
AU - Rulli, I.
AU - Moscatelli, A.
AU - Micalizzi, C.
AU - Savron, F.
AU - Sagredini, R.
AU - Genoni, G.
AU - Binotti, M.
AU - Caramelli, F.
AU - Fae, M.
AU - Pettenazzo, A.
AU - Stritoni, V.
AU - D'Amato, L.
AU - Zito Marinosci, G.
AU - Calderini, E.
AU - Scalia Catenacci, S.
AU - Berardi, A.
AU - Torcetta, F.
AU - Bonanomi, E.
AU - Bonacina, D.
AU - Ivani, G.
AU - Santuz, P.
N1 - Cited By :1
Export Date: 19 March 2021
Correspondence Address: Biban, P.; Department of Neonatal and Paediatric Critical Care, Italy; email: paolo.biban@aovr.veneto.it
PY - 2020
Y1 - 2020
N2 - Introduction Some evidence indicates that exogenous surfactant therapy may be effective in infants with acute viral bronchiolitis, even though more confirmatory data are needed. To date, no large multicentre trials have evaluated the effectiveness and safety of exogenous surfactant in severe cases of bronchiolitis requiring invasive mechanical ventilation (IMV). Methods and analysis This is a multicentre randomised, placebo-controlled, double-blind study, performed in 19 Italian paediatric intensive care units (PICUs). Eligible participants are infants under the age of 12 months hospitalised in a PICU, suffering from severe acute hypoxaemic bronchiolitis, requiring IMV. We adopted a more restrictive definition of bronchiolitis, including only infants below 12 months of age, to maintain the population as much homogeneous as possible. The primary outcome is to evaluate whether exogenous surfactant therapy (Curosurf, Chiesi Pharmaceuticals, Italy) is effective compared with placebo (air) in reducing the duration of IMV in the first 14 days of hospitalisation, in infants suffering from acute hypoxaemic viral bronchiolitis. Secondary outcomes are duration of non-invasive mechanical ventilation in the post-extubation phase, number of cases requiring new intubation after previous extubation within 14 days from randomisation, PICU and hospital length of stay (LOS), duration of oxygen dependency, effects on oxygenation and ventilatory parameters during invasive mechanical respiratory support, need for repeating treatment within 24 hours of first treatment, use of other interventions (eg, high-frequency oscillatory ventilation, nitric oxide, extracorporeal membrane oxygenation), mortality within the first 14 days of PICU stay and before hospital discharge, side effects and serious adverse events. Ethics and dissemination The trial design and protocol have received approval by the Italian National Agency for Drugs (AIFA) and by the Regional Ethical Committee of Verona University Hospital (1494CESC). Findings will be disseminated through publication in peer-reviewed journals, conference/meeting presentations and media. Trial registration number Clinicaltrials.gov, issue date 22 May 2019. NCT03959384. ©
AB - Introduction Some evidence indicates that exogenous surfactant therapy may be effective in infants with acute viral bronchiolitis, even though more confirmatory data are needed. To date, no large multicentre trials have evaluated the effectiveness and safety of exogenous surfactant in severe cases of bronchiolitis requiring invasive mechanical ventilation (IMV). Methods and analysis This is a multicentre randomised, placebo-controlled, double-blind study, performed in 19 Italian paediatric intensive care units (PICUs). Eligible participants are infants under the age of 12 months hospitalised in a PICU, suffering from severe acute hypoxaemic bronchiolitis, requiring IMV. We adopted a more restrictive definition of bronchiolitis, including only infants below 12 months of age, to maintain the population as much homogeneous as possible. The primary outcome is to evaluate whether exogenous surfactant therapy (Curosurf, Chiesi Pharmaceuticals, Italy) is effective compared with placebo (air) in reducing the duration of IMV in the first 14 days of hospitalisation, in infants suffering from acute hypoxaemic viral bronchiolitis. Secondary outcomes are duration of non-invasive mechanical ventilation in the post-extubation phase, number of cases requiring new intubation after previous extubation within 14 days from randomisation, PICU and hospital length of stay (LOS), duration of oxygen dependency, effects on oxygenation and ventilatory parameters during invasive mechanical respiratory support, need for repeating treatment within 24 hours of first treatment, use of other interventions (eg, high-frequency oscillatory ventilation, nitric oxide, extracorporeal membrane oxygenation), mortality within the first 14 days of PICU stay and before hospital discharge, side effects and serious adverse events. Ethics and dissemination The trial design and protocol have received approval by the Italian National Agency for Drugs (AIFA) and by the Regional Ethical Committee of Verona University Hospital (1494CESC). Findings will be disseminated through publication in peer-reviewed journals, conference/meeting presentations and media. Trial registration number Clinicaltrials.gov, issue date 22 May 2019. NCT03959384. ©
KW - clinical trials
KW - paediatric infectious disease & immunisation
KW - paediatric intensive & critical care
KW - paediatric thoracic medicine
KW - nitric oxide
KW - poractant
KW - acute disease
KW - Article
KW - assisted ventilation
KW - child hospitalization
KW - clinical outcome
KW - controlled study
KW - disease severity
KW - double blind procedure
KW - drug efficacy
KW - drug safety
KW - drug tolerability
KW - extracorporeal oxygenation
KW - extubation
KW - female
KW - high frequency oscillatory ventilation
KW - hospital discharge
KW - hospital mortality
KW - human
KW - hypoxemia
KW - infant
KW - infant mortality
KW - intermittent mandatory ventilation
KW - invasive ventilation
KW - Italy
KW - length of stay
KW - male
KW - multicenter study
KW - noninvasive ventilation
KW - oxygen therapy
KW - oxygenation
KW - pediatric intensive care unit
KW - randomized controlled trial
KW - treatment duration
KW - viral bronchiolitis
U2 - 10.1136/bmjopen-2020-038780
DO - 10.1136/bmjopen-2020-038780
M3 - Article
VL - 10
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 10
ER -