Efficacy and Safety of Curosurf® in Patients Invasively Ventilated for Severe Bronchiolitis Under 12 Months of Age
Bronchiolitis, Viral
About this trial
This is an interventional treatment trial for Bronchiolitis, Viral
Eligibility Criteria
Inclusion Criteria:
- Aged > 40 weeks (correct gestational age) and < 12 months.
- Patient intubated and mechanically ventilated for at least 6 hours, with expected requirement of ventilatory support of at least 24 hours.
- Clinical picture strongly suggestive for acute bronchiolitis (fever of probable viral origin, fine crackles, prolonged expiration, lung hyperexpansion on chest X-ray)
- Moderate or severe pediatric acute respiratory distress syndrome, defined by a Oxygenation Index (OI) > 8 or an Oxygen Saturation Index (OSI) > 7.5
- Written informed consent obtained from both parents
Exclusion Criteria:
- Severe prematurity (gestational age < 32 weeks). Patients with gestational age less than 32 weeks will be excluded because they are considered at high risk for respiratory pathology following their severe prematurity. This consideration does not apply in successive gestational ages. Therefore patients with mild prematurity, i.e. with gestational age equal to or greater than 32 weeks, are not to be excluded.
- Recent phase of oxygen dependency (need for oxygen supplementation to maintain satO2 > 94% in the four weeks preceding hospitalization in Pediatric ICU)
- Invasive mechanical ventilation for more than 24 hours.
- Oxygenation index (OI) > 30
- Cyanotic congenital heart disease
- Untreated pneumothorax
- Neuromuscular diseases
- Severe Neurological Alterations
- Other severe congenital anomalies
- Indication not to attempt resuscitation
- Patient already recruited for other clinical studies
Sites / Locations
- Azienda Ospedaliera Universitaria Integrata Verona
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Surfactant replacement (Curosurf)
Ambient Air
Broncho-alveolar lavage (BAL) with 25 mg / kg of Curosurf, diluted 1:10 with physiological solution, divided in two aliquots administered with a endotracheal tube in two different postures (1st BAL on right decubitus, 2nd BAL on left decubitus). Following supplementation of a dose of 25 mg / kg of Curosurf, diluted with physiological solution 1: 2 (1 ml = 40 mg of surfactant), given in two aliquots with endotracheal tube in two different postures (1st on right decubitus, 2nd on left decubitus). The treatment assigned may be repeated at least 12 hours later and in any case within 24 hours from the first treatment, at the same dosage and with the same method of administration
Broncho-alveolar lavage (BAL) with air, administered with a endotracheal tube in two different postures (1st BAL on right decubitus, 2nd BAL on left decubitus). Following supplementation of air given with endotracheal tube in two different postures (1st on right decubitus, 2nd on left decubitus). The treatment assigned may be repeated at least 12 hours later and in any case within 24 hours from the first treatment, at the same dosage and with the same method of administration