Placebo-controlled study to evaluate the efficacy and safety of Curosurf in patients under 12 months of age with moderate or severe acute respiratory distress syndrome during bronchiolitis with the need for invasive mechanical ventilation

Randomized multicentre-controlled, placebo-controlled (1: 1) study to evaluate the efficacy and safety of Curosurf in patients under 12 months of age with moderate or severe acute respiratory distress syndrome (ARDS) Bronchiolitis, with the need for invasive mechanical ventilation. - SURFABRON

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001768-39-IT

Enrollment

172

Registered

2020-11-04

Start date

2018-03-07

Completion date

Unknown

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute severe hypoxic bronchiolitis MedDRA version: 20.1 Level: LLT Classification code 10000686 Term: Acute bronchiolitis System Organ Class: 100000004862

Interventions

Trade Name: CUROSURF - 80 MG/ML SOSPENSIONE PER INSTILLAZIONE ENDOTRACHEOBRONCHIALE 1 FLACONCINO 3 ML Product Name: CUROSURF Product Code: [028221024] Pharmaceutical Form: Endotracheopulmonary instil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age> 40 weeks (correct gestational age) and Oxygenation Index (OI)> 8 or Oxygen Saturation Index (OSI)> 7.5 5. Written informed consent obtained by both parents Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Severe premature prematurity (gestational age 95% in the Four Weeks Prior to Pediatric Intensive Care) 3. Mechanical invasive ventilation for more than 24 hours. 4. Oxygenation index - OI> 30 5. Congenital Cyanopathic Cardiopathies 6. Untreated pneumothorax 7. Neuromuscular Diseases Severe neurological alterations 9. Other serious congenital anomalies 10. Indication not to try resuscitation 11. Patient already recruited for other clinical trials

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate whether treatment with Curosurf is effective compared to placebo (air) in reducing the duration of invasive mechanical ventilation during the first 14 days of admission, in children under 12 months of acute hypoxic bronchiolitis, viral origin, admitted to therapy intensive.;Secondary Objective: Assess whether the treatment is effective compared to placebo in reducing the duration of non-invasive mechanical ventilation in post-extubation; is effective compared to placebo in reducing the number of cases requiring new intubation after previous extubation in 14 days from randomization; compared to placebo in reducing days of stay in IT; reduce hospital days; reduce the duration of oxygen dependence; improve oxygenation and ventilation of pts compared to placebo; Improve oxygenation parameters during invasive mechanical ventilation support; reduce the need to repeat treatment within 24h from the first; reduce the use of other unconventional therapies during treatment; the effectiveness in terms of mortality within the first 14 days of admission to IT and in any case by the discharge from the hospital; security and tolerability.;Primary end point(s): Number of free days of invasive mechanical ventilation from randomization to day 14, considering the first successful extubation (at least 48 hours without reintroduction);Timepoint(s) of evaluation of this end point: From randomization to day 14	—

Measure

Time frame

Main Objective: To evaluate whether treatment with Curosurf is effective compared to placebo (air) in reducing the duration of invasive mechanical ventilation during the first 14 days of admission, in children under 12 months of acute hypoxic bronchiolitis, viral origin, admitted to therapy intensive.;Secondary Objective: Assess whether the treatment is effective compared to placebo in reducing the duration of non-invasive mechanical ventilation in post-extubation; is effective compared to placebo in reducing the number of cases requiring new intubation after previous extubation in 14 days from randomization; compared to placebo in reducing days of stay in IT; reduce hospital days; reduce the duration of oxygen dependence; improve oxygenation and ventilation of pts compared to placebo; Improve oxygenation parameters during invasive mechanical ventilation support; reduce the need to repeat treatment within 24h from the first; reduce the use of other unconventional therapies during treatment; the effectiveness in terms of mortality within the first 14 days of admission to IT and in any case by the discharge from the hospital; security and tolerability.;Primary end point(s): Number of free days of invasive mechanical ventilation from randomization to day 14, considering the first successful extubation (at least 48 hours without reintroduction);Timepoint(s) of evaluation of this end point: From randomization to day 14

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Secondary

Measure	Time frame
Secondary end point(s): Number of days off mechanical ventilation noninvasive, from randomization to day 14.; Necessity of new intubation, after previous extubation, within 14 days from randomization; (1) Number of days free from intensive care, from randomization to day 14; (2) Total number of days of hospital stay in TIP from randomization; (1) Number of free days from hospital stay, from randomization to day 14; (2) Total number of days of hospital stay by randomization;; Number of free days from oxygen supplementation, from randomization to day 14;; Values of oxygenation indices (Oxygenation Saturation Index, Oxygenation Index) and ventilation indices (PaCO2, End Tidal CO2) detected 15 minutes before treatment and remote administration of 2, 6, 12, 24, 36 and 48 hours (for indexes of oxygenation if present arterial line);; Values of mechanical ventilation parameters, such as current volume (Vt), positive pressure of end exhalation (PEEP), peak pressure inspiratory (PIP), respiratory rate, FiO2, inspirational time (Ti) and average pressure in the streets (MAP), detected 15 minutes before administration of the treatment and at a distance of 2,6, 12, 24, 36 and 48 hours after treatment; Number of Patients Repeated treatment (medication or placebo) within 24 hours of first treatment; Number of patients undergoing therapy not Conventional (HFOV, ECMO, Nitric Oxide) during the first 14 days; (1) Mortality during the first 14 days of hospitalization hospital (2) Mortality within discharge from the hospital; number of severe desaturation episodes (SatO2 <75%) during treatment; number of severe bradycardia episodes (FC <80 / min) during administration of treatment; number of extreme bradycardia episodes or cardiac arrest that need chest compressions and / or administration of resuscitation drugs (eg adrenaline) during treatment; number of episodes of pulmonary haemorrhage; number of pneumothorax episodes;Timepoint(s) of evaluation of this end point: from randomization	—

Measure

Time frame

Secondary end point(s): Number of days off mechanical ventilation noninvasive, from randomization to day 14.; Necessity of new intubation, after previous extubation, within 14 days from randomization; (1) Number of days free from intensive care, from randomization to day 14; (2) Total number of days of hospital stay in TIP from randomization; (1) Number of free days from hospital stay, from randomization to day 14; (2) Total number of days of hospital stay by randomization;; Number of free days from oxygen supplementation, from randomization to day 14;; Values of oxygenation indices (Oxygenation Saturation Index, Oxygenation Index) and ventilation indices (PaCO2, End Tidal CO2) detected 15 minutes before treatment and remote administration of 2, 6, 12, 24, 36 and 48 hours (for indexes of oxygenation if present arterial line);; Values of mechanical ventilation parameters, such as current volume (Vt), positive pressure of end exhalation (PEEP), peak pressure inspiratory (PIP), respiratory rate, FiO2, inspirational time (Ti) and average pressure in the streets (MAP), detected 15 minutes before administration of the treatment and at a distance of 2,6, 12, 24, 36 and 48 hours after treatment; Number of Patients Repeated treatment (medication or placebo) within 24 hours of first treatment; Number of patients undergoing therapy not Conventional (HFOV, ECMO, Nitric Oxide) during the first 14 days; (1) Mortality during the first 14 days of hospitalization hospital (2) Mortality within discharge from the hospital; number of severe desaturation episodes (SatO2 <75%) during treatment; number of severe bradycardia episodes (FC <80 / min) during administration of treatment; number of extreme bradycardia episodes or cardiac arrest that need chest compressions and / or administration of resuscitation drugs (eg adrenaline) during treatment; number of episodes of pulmonary haemorrhage; number of pneumothorax episodes;Timepoint(s) of evaluation of this end point: from randomization

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Countries

Italy

Contacts

Public ContactUnità Ricerca Clinica

AZIENDA OSPEDALIERA INTEGRATA UNIVERSITARIA DI VERONA

supporto.noprofit@aovr.veneto.it0458127043

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 25, 2026