The Bronchiolitis Endotracheal Surfactant Study (BESS)
Research type
Research Study
Full title
The efficacy and mechanism of surfactant therapy for critically ill infants with bronchiolitis: The Bronchiolitis Endotracheal Surfactant Study.
IRAS ID
220853
Contact name
Calum Gracie Semple
Contact email
Sponsor organisation
University of Liverpool
Eudract number
2018-001169-18
Duration of Study in the UK
3 years, 7 months, 30 days
Research summary
Bronchiolitis is a winter viral chest infection that causes breathing difficulties in babies. Bronchiolitis is the single most common reason for hospital admission of babies in the UK. Over 25,000 babies are admitted to hospital in England each year.
There is no vaccine or specific treatment. Breathing fails in very severe cases, and these babies need intensive care to go on a breathing machine called a mechanical ventilator.
Surfactant is in the liquid produced in healthy lungs that allows the lungs to inflate more easily. Surfactant therapy is safe and established for use in premature babies for over 30 years.
We want to find out if surfactant reduces the time critically ill babies with bronchiolitis spend on a mechanical ventilator.
BESS will take place in Paediatric Intensive Care Units (PICUs) in hospitals in the UK. We will give surfactant to 142 babies age under 6 months and a dummy procedure to 142 babies. The PICU staff and research team will not know who gets what until the end of the study.
We will do tests to measure how much surfactant the babies are making; how much of the surfactant that we give is staying in the lungs; which virus and bacteria are infecting the airways and how much inflammation is in the airways.
Babies that have severe bronchiolitis often have more episodes of chestiness and wheeze in the months after their illness than those that did not have bronchiolitis. It is possible that the surfactant given in this study may help reduce these symptoms. We will ask parents to complete a questionnaire at 6 and 12 months after their baby goes home to tell us about any respiratory symptoms they notice in their baby.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0427
Date of REC Opinion
4 Sep 2018
REC opinion
Favourable Opinion