Table 3

Trial registration data: SURFABRON

Data categoryInformation
Primary registry and trial identifying numberClinicalTrials.gov NCT03959384; Pre-results.
Date of registration in primary registry22 May 2019
Secondary identifying numbersEUDRACT 2017-001768-39
Source(s) of monetary or material supportInsurance of the trial covered by Chiesi Pharmaceutical
Primary sponsorAzienda Ospedaliera Universitaria Integrata Verona, Italy
Secondary sponsor(s)None
Contact for public queriesPaolo Biban, MD (paolo.biban@aovr.veneto.it)
Contact for scientific queriesPaolo Biban, MD (paolo.biban@aovr.veneto.it), Verona University Hospital, Italy
Public titleEfficacy and safety of exogenous surfactant therapy in patients under 12 months of age invasively ventilated for severe bronchiolitis
Scientific titleEfficacy 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
Countries of recruitmentItaly
Health condition(s) or problem(s) studiedSurfactant therapy, viral bronchiolitis
Intervention(s)Active comparator: exogenous porcine surfactant (Curosurf 50 mg/kg endotracheally);
Placebo comparator: ambient air
Key inclusion and exclusion criteriaAges eligible for study: <12 months; sexes eligible: both; accepts healthy volunteers: no
Inclusion criteria: infants <12 months; patients hospitalised in an intensive care unit, mechanically ventilated.
Exclusion criteria: (1) Severe prematurity (gestational age <32 weeks). (2) Need for O2 supplementation to maintain SatO2>94% in the 4 weeks preceding hospitalisation in the PICU. (3) Invasive mechanical ventilation for more than 24 hours. (4) Oxygenation index (OI) >30. (5) Cyanotic congenital heart disease. (6) Untreated pneumothorax. (7) Neuromuscular diseases. (8) Severe neurological abnormalities. (9) Other severe congenital anomalies. (10) Indication not to attempt resuscitation. (11) Patient already recruited for other clinical studies.
Study typeInterventional
Allocation: randomised; Intervention model: parallel assignment, multicentre, double blind, placebo-controlled
Primary purpose: reduction of duration of invasive mechanical support
Phase III
Date of first enrolment9 January 2019
Target sample size172
Recruitment statusRecruiting
Primary outcome(s)To evaluate whether Curosurf treatment is effective compared with placebo (air) in reducing the duration of invasive mechanical ventilation in the first 14 days of hospitalisation, in infants under the age of 12 months, admitted in a paediatric intensive care unit (PICU) for acute hypoxaemic bronchiolitis of viral origin.
Key secondary outcomesEvaluate whether Curosurf treatment is effective compared with placebo in reducing: 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 LOS; duration of O2 dependency.
  • LOS, length of stay.