The efficacy and mechanism of surfactant therapy for critically ill infants with bronchiolitis: the Bronchiolitis Endotracheal Surfactant Study (BESS)

Phase 1

• 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.; MedDRA version: 20.1 Level: PT Classification code 10038718 Term: Respiratory syncytial virus bronchiolitis System Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1 Level: PT Classification code 10065188 Term: Lower respiratory tract infection viral System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-001169-18-GB
• Lead Sponsor: niversity Of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 284

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
F.1.3.1 Number of subjects for this age range 0

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

Study & Design

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