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 ventilatio

Phase 1

• Conditions: Acute severe hypoxic bronchiolitis; MedDRA version: 20.1Level: LLTClassification code 10000686Term: Acute bronchiolitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-001768-39-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

1. Age> 40 weeks (correct gestational age) and <12 months.
2. Patient intubated and mechanically ventilated for at least 6 hours, with ventilation support requirements of at least 24 hours.
3. Clinical framework strongly suggestive of acute bronchiolitis (fever of probable viral origin, creeping rantules, prolonged exhalation, inflammation of the pulmonary arteries in chest x-rays)
4. Moderate or severe pediatric acute respiratory distress syndrome (OI)> 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

1. Severe premature prematurity (gestational age <32 weeks)
2. Recent Oxygen Dependence (Oxygen Supplement Need to Keep SatO2> 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified