A major UK-led clinical trial has found that a treatment commonly used to help premature babies breathe offers no benefit for infants on life support with severe bronchiolitis - a seasonal viral illness that hospitalises thousands of babies each year.
The result was announced today (Thursday 26 June) at the 34th International Congress of the European Society for Paediatric and Neonatal Intensive Care (ESPNIC) in Alicante, Spain.
Bronchiolitis occurs when a virus, most often RSV (respiratory syncytial virus), infects a baby's lungs. There is no treatment for RSV infection. Bronchiolitis is most severe in premature and newborn babies. Babies with bronchiolitis have reduced surfactant in their lungs, similar to prematurely born babies. Surfactant is routinely used to help premature babies breathe more easily, so the study team wanted to test whether it would also be effective in babies with bronchiolitis.
Funded by the UK's National Institute for Health and Care Research (NIHR) and Chiesi Farmaceutici SpA, Italy, the BESS trial is the largest-ever randomised study of surfactant for bronchiolitis. The work ran across 15 children's hospitals in England, Scotland, and Northern Ireland and involved 232 critically ill babies. However, surfactant did not reduce the time they needed to be on a ventilator (life-support breathing machine).
Professor Calum Semple OBE, the study's lead from the University of Liverpool and Alder Hey Children's NHS Foundation Trust, said: "The treatment was safe, but it didn't make any difference to how long babies stayed on ventilators. We had hoped that surfactant might speed up recovery for these very sick babies, but the evidence doesn't support this."
Bronchiolitis - most often caused by RSV (respiratory syncytial virus) - is the leading reason why babies are admitted to hospital in the UK during winter. It typically affects babies under one year old and can be especially severe in those born prematurely. While most of the twenty-five thousand babies admitted will recover with oxygen and fluids, around a thousand of the most unwell require intensive care and a ventilator to support their breathing. Currently, there is no other treatment for bronchiolitis.
The BESS trial was designed to give families and clinicians clear answers. It ran over six winter seasons from 2019 to 2024 and was funded by the UK's National Institute for Health and Care Research (NIHR) and Chiesi Farmaceutici SpA, Italy.
Professor Semple added: "Importantly, we've shown this treatment is safe, but it should not be used routinely for critically ill babies with bronchiolitis. We will continue to research better ways to help these vulnerable infants. Meanwhile, I urge Mums-to-be to accept the offer of the RSV vaccine during pregnancy, which will protect their newborn babies from severe bronchiolitis."
The researchers emphasise that surfactant therapy remains essential for premature newborn babies and advocate for further studies to explore targeted treatments for bronchiolitis.
