EUCTR2018-001169-18-GB
Active, not recruiting
Phase 1
The efficacy and mechanism of surfactant therapy for critically ill infants with bronchiolitis: The Bronchiolitis Endotracheal Surfactant Study. - The Bronchiolitis Endotracheal Surfactant Study (BESS)
niversity Of Liverpool0 sites284 target enrollmentAugust 21, 2018
ConditionsCritical Illness due to Bronchiolitis of infancy requiring conventional invasive Mechanical Ventilation (MV) Diagnosis of bronchiolitis per clinical criteria defined in national guidance NICE-NG9.MedDRA version: 20.1 Level: PT Classification code 10038718 Term: Respiratory syncytial virus bronchiolitis System Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1 Level: PT Classification code 10065188 Term: Lower respiratory tract infection viral System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsCurosurf
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Critical Illness due to Bronchiolitis of infancy requiring conventional invasive Mechanical Ventilation (MV) Diagnosis of bronchiolitis per clinical criteria defined in national guidance NICE-NG9.
- Sponsor
- niversity Of Liverpool
- Enrollment
- 284
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Term\-born infants \< 26 weeks old and preterm\-born infants \< 26 weeks corrected age†
- •2\.Diagnosis of bronchiolitis (see below)
- •3\.Requires conventional invasive MV via tracheal intubation
- •4\. Parent or person with parental responsibility has given written informed consent for trial participation
- •†Premature born infants have their age corrected to account for weeks of lost gestation
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range 0
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •1\.Major congenital anomalies, including complex or haemodynamically compromising cardiac anomalies.
- •2\.Congenital neuromuscular disease
- •3\.Already intubated for MV for \>48 hours or likely to have been intubated for MV for \>48 hours by randomisation
- •4\.Have received or are receiving extracorporeal membrane oxygenation (ECMO) or oscillation during this episode of bronchiolitis
- •5\.Have received or are receiving intratracheal administration of any surfactant during this episode of bronchiolitis
- •6\.Receiving MV for primary apnoea rather than respiratory failure
- •7\.A decision to wean to extubation has already been made
- •8\.Clinical judgement of futility
Outcomes
Primary Outcomes
Not specified
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