Information for Parents – Balloon Trial

smiling baby lying on its side facing camera

The BALLOON Trial

Babies born early (under 30 weeks of gestation) have lungs and immune systems that are still developing. After discharge home, chest infections can cause difficulties for some babies who are born early.

The BALLOON study is a national clinical trial asking if Bactek, an oral spray containing inactivated bacteria (it cannot cause infection), can help reduce chest infections in babies born early. The aim is to develop the immune development so the baby is ready and prepared to fight viral infections.

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 ensuring the study is being run correctly.

Every effort will be made to ensure that any information about your baby that leaves the hospital has identifiers removed so that your baby cannot be recognised from it. This is usually done by a member of the study team at your baby’s hospital and/or by the Centre for Trials Research upon receipt.

What happens if I change my mind about my baby taking part?

You can stop your baby taking part at any time. The care your baby receives will not be affected.

If you decide to stop taking part, we would stop giving study treatment (if not finished). We will also ask whether 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 information already collected. We may also be required to collect limited information about side effects, if requested by 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 we can keep in touch with you. We would like to notify you of the results of the BALLOON trial when published.