| Latest Recruitment | 22-01-2025 |
|---|---|
| Congratulations to: | |
| Total Recruited | 0 |
| Recruitment Target | 542 |
About the BALLOON Trial
Babies born early (under 30 weeks gestation) are born with under-developed lungs and immune systems so sometimes need help with their breathing after birth. After discharge, chest infections can cause difficulties for some babies who were born early.
The study called “Bacterial mucosal immunotherapy for prevention of lower respiratory tract infections in preterm born infants” or the BALLOON study is a national clinical trial investigating if Bactek, an oral spray that contains harmless dead bacteria, can help reduce chest infections in babies born early at less than 30 weeks gestation.
Lung disease in prematurely born babies
Although advances in the treatment of prematurely born babies has improved substantially over the last thirty years, many babies are still at risk of developing the lung disease.
Like all babies, premature babies will get infections which they generally deal with well. However, over half will get chest infections (“pneumonia” or “bronchiolitis”, commonly due to viruses) which can further damage the lungs. Many babies will need to be seen by their GPs or in A&E and some are admitted to hospital.
There are very few treatments available to prevent viral chest infections except against the virus called RSV (Respiratory Syncytial Virus).
Bactek
Our study will determine if Bactek given daily for about a year can help to develop the baby’s immune system, like a vaccine, so that the baby is ready and prepared to fight chest infections. Reducing chest infections may help the lungs of early born babies work better. The best way to find out if Bactek reduces chest infections is to compare early born babies who are given Bactek with those who are not. In total, 542 babies born prematurely will be enrolled.
Neonatal units
The trial will involve approximately 12-14 neonatal intensive care units around the UK and will last for 4 years.
Funding
BALLOON is funded by the UK’s National Institute of Health Research, EME Programme (Reference NIHR156651).
Trial collaboration
The trial is being led by Professor Sailesh Kotecha from the Department of Child Health in the School of Medicine, and coordinated by the Centre for Trials Research, both based at Cardiff University. The other co-applicants include Dr Janet Berrington from Newcastle, Marie Hubbard from Leicester Royal Infirmary, Professor Jonathan Grigg from Queen Mary University of London, Professor Ian Humphreys, Dr John Lowe, Dr David Gillespie, Dr Kirsten Ladell, Dr Emma Thomas-Jones and Dr Sarah Kotecha from Cardiff University.
Trial partners
