| Recruitment Summary | |
| Latest Recruitment | 27th January 2026 |
| Congratulations to | Royal Preston Hospital |
| Total Recruited | 61 |
| Recruitment Target | 542 |
| Progress | 11.3% |
The BALLOON Trial
Babies born very early (before 30 weeks of gestation) have under-developed lungs and immune systems. After discharge home, chest infections can cause significant difficulties for some babies born prematurely.
The BALLOON study is a national clinical trial investigating if Bactek, an oral spray containing harmless, inactivated bacteria, can reduce chest infections in babies born before 30 weeks of gestation. Bactek is designed to help stimulate and train the baby’s immune system during early life.
Lung disease in prematurely born babies
Despite many advances in neonatal care over the past 30 years, many babies born prematurely remain at risk of developing chronic lung disease, including bronchopulmonary dysplasia (BPD).
After discharge, like all babies, babies born prematurely will experience infections, which they usually manage well. However, more than half of babies born very early will develop chest infections such as pneumonia or bronchiolitis – most commonly due to viruses – which can cause further lung injury. Many babies require review by their GP or attendance at Accident & Emergency departments, and some require hospital admission.
Currently, there are very few treatments available to prevent or treat viral chest infections, apart from protection against the RSV (respiratory syncytial virus). There is, therefore, an urgent need for interventions that can offer broader protection against multiple respiratory viruses.
Bactek
Our BALLOON study will find out if Bactek spray, given daily for one year after discharge home, can help strengthen the premature baby’s immune system. By improving the immune system, Bactek should help premature babies better fight chest infections, thereby reducing lung damage during this vulnerable period of development.
The most reliable way to determine whether Bactek is effective is to compare outcomes between babies who receive Bactek and those who do not. In total, 542 babies born prematurely will be enrolled in the study.
Neonatal units
The trial will involve 20 – 25 neonatal intensive care units around the UK and will last for 4 to 5 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 Cardiff University, and is 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.
