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
Conditions
Interventions
Trade Name: Curosurf
Product Name: Curosurf
Pharmaceutical Form: Endotracheopulmonary instillation, suspension
INN or Proposed INN: Poractant alfa
Sponsors
University Of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Term-born infants =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: This is an event which may occur at any time following intubation; there is no specific timepoint when this will be evaluated.; Main Objective: BESS is a study that comprises three work packages. The Trial is Work Package A (WP-A), the parent and staff experience substudy is work package B (WP-B) and the mechanistic substudy is work package C (WP-C). The hypothesis we are testing in The Trial (WP-A) is: Endotracheal surfactant reduces duration of mechanical ventilation by 18 hours. This trial will test whether giving surfactant into the lungs of babies suffering from severe bronchiolitis reduces the time they spend on a mechanical ventilator to help them breathe. We will do this by measuring the total time babies spend on a mechanical ventilator in hours and comparing the time required by babies given a surfactant (called poractant alfa) to babies given air (a dummy or placebo treatment). "18 hours" is included in the hypothesis as this is considered to be the smallest period of time that would be of benefit to a baby's wellbeing. The study will run over 3 winter seasons and involve about 284 babies. ; Secondary Objective: Secondary objectives of the BESS Trial (Work Package A of the BESS study) are: 1. To describe the impact of the intervention on infants’ long-term respiratory symptoms 2. To describe secondary outcomes of efficacy including physiological indices and duration of other modes of respiratory support. 3. To assess the safety of the intervention for infants with life-threatening bronchiolitis We are also conducting sub-studies that leverage the opportunity the study provides for exploratory and translational work. Work Package B is the study of parent and staff experiences, the objective of which is to explore staff and parent experi | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): BESS consists of three separate work packages: In work package A (WP-A) the secondary endpoints are: 1. Time from randomisation to meeting study criteria for readiness for Spontaneous Breathing Test 2. Number of trial interventions given 3. Change over time from baseline of Ventilation Index (VI) and Oxygenation Index (OI) Oxygen Saturation Index (OSI) while mechanically ventilated, or other respiratory support & SpO2/FiO2 (SF) ratio while mechanically ventilated and receiving supplemental oxygen 4. Duration of oxygen supplementation 5. Use of steroids to assist extubation 6. Duration of post-extubation non-invasive respiratory support 7. Duration of stay on PICU and in hospital 8. The score (value) of patient reported outcome measure of respiratory systems in the “Liverpool Respiratory Symptom Questionnaire” (LRSQ) In work package B (WP-B) the aim is to explore parents' experience of participation in a trial where recruitment occurs during the early (acute - emergency) phase of admission at the time of particularly heightened parental anxiety due to critical illness of their baby. The end point is: 9. Staff and parent experiences of trial recruitment, consent and conduct (assessed on data from season 1) In work package C (WP-C) the aim is to explore the mechanisms for treatment efficacy and failure by describing associations between trial outcome with markers of infection, inflammation and surfactant composition in patient BAL fluid. Secondary end points are: 10. At all sites indicators of inflammation and infection in BAL fluid from all infants 11. At all sites composition and concentration of surfactant phospholipids in BAL fluid from all infants 12. At all sites concentration of surfactant proteins | — |
Countries
United Kingdom
Contacts
Public ContactBESS Trial
Clinical Trials Research Centre (CTRC)
Outcome results
None listed