News
We plan to start recruitment to BALLOON in September 2024 and are currently busy setting the trial up. We hope to involve 10-12 neonatal units across the UK.
Confidentiality
All the information collected about your baby during the study will be handled according to all applicable ethical and legal requirements.
Your baby’s personal information will be kept strictly confidential and will only be accessed by people working on the study or working to ensure the study is being run correctly.
Every effort will be made to ensure that any information about your baby that leaves the hospital will have your baby’s identifiers removed so that your baby cannot be recognised from it; this information will usually be removed by a member of the study team at your baby’s hospital but may also be removed by the Centre for Trials Research upon receipt.
What happens if I change my mind about my baby taking part?
If at any point you decide you want your baby to stop taking part in the study, the care your baby receives will not be affected. If you do decide for your baby to stop taking part we would stop giving study treatment (if not finished) and you tell us you would like to stop, we will also ask you if you would like your baby to:
- continue to complete study follow up (data collection and whether nose/cheek swabs can be taken),
- continue to be part of the optional sub studies if your local neonatal unit is involved in these and you have said yes to being involved in them.
- stop taking part with no more study follow up.
If you withdraw your baby from the study, we will keep the information about your baby that we have already obtained. We may be required to collect some limited information about your baby and about side effects your baby may have as a result of taking part in the trial. This will only be collected if required by the Regulatory Authorities.
Keep in Touch
Please let us know if your family circumstances change, e.g. you move house or change your phone number, so that we can keep in touch with you. We would like to notify you of the results of the BALLOON trial when published.