Demonstration guide — always follow the labelled treatment and current instructions supplied by your BALLOON team
Preterm Lung Health Research
A clinical trial for babies born very prematurelyPractical guide for participating families
Taking part at home
A clear guide to the daily routine, follow-up and what to do when plans change or your baby becomes unwell.
Treatment at a glance
Once daily until one year corrected age
Treatment begins between 37 and 43 weeks’ postmenstrual age, or at discharge if earlier. Each baby receives either Bactek or matching placebo; families and clinical teams normally remain unaware of allocation.
Daily treatment
A simple, repeatable routine
Training from the research team should be completed before treatment is given at home.
- 01
Choose a regular time
Give the study treatment once daily at the time agreed with your trial team. Linking it to an established routine may help.
- 02
Follow the labelled instructions
Use only the dose, preparation method and administration technique supplied by the BALLOON team.
- 03
Record as requested
Complete the study record or app promptly, including missed treatment and relevant healthcare contacts.
- 04
Keep supplies secure
Store the treatment exactly as instructed, out of reach of children, and retain its trial label and packaging.
- 05
Contact the team early
Ask for advice if treatment is lost, damaged, spilled, appears different, or may have been stored incorrectly.
When the routine changes
Common situations
These principles reduce the risk of accidental extra dosing or use of treatment whose integrity is uncertain.
A dose is missed
Do not double the next dose. Record the missed dose and follow the written guidance supplied by your trial team.
Your baby spits out or vomits after treatment
Do not automatically repeat the dose. Use the current written instructions or contact the research nurse at your baby’s local hospital.
The bottle is lost or damaged
Keep it away from children and contact the team for advice and replacement. Do not transfer treatment into another container.
Storage instructions may not have been followed
Do not assume the treatment remains suitable. Quarantine it safely and contact the research nurse at your baby’s local hospital.
You are travelling or staying elsewhere
Plan ahead with the team. Take the labelled treatment, written guidance and study contact details with you.
You want a break or wish to stop
Contact the team. Stopping treatment is your choice and does not affect usual care; follow-up options can be discussed separately.
Study follow-up
What information may be collected?
Timely, accurate information is essential even when treatment is missed or your baby has no respiratory problems.
Healthcare contacts
Tell the team about unscheduled GP reviews, emergency-department attendances and hospital admissions, particularly for breathing problems.
Breathing symptoms
Record cough, wheeze or other symptoms as requested. Every family is given a WheezeScan to support symptom recording; it does not replace clinical assessment.
Medicines
Report respiratory medicines and other information specified in the study record.
Growth and family impact
Follow-up may include growth measures and questions about time away from work or nursery.
Samples
Swabs may help identify viruses associated with respiratory infections; follow the provided collection and return instructions.
!
If your baby becomes unwell
Contact your baby’s local clinical service first
Use the clinical contact provided by your baby’s hospital, or contact their neonatal team, GP or NHS 111. In an emergency call 999. Never delay care while waiting for a research contact.
- 1. Obtain medical care
Follow advice from your baby’s local clinical service about immediate treatment.
- 2. Tell the research nurse
After care has been arranged, contact the research nurse at your baby’s local hospital as instructed.
- 3. Ask about study treatment
The local hospital research nurse will advise whether any interruption or additional reporting is needed.
Side effects and safety
Report anything that concerns you
The trial collects adverse reactions and other safety information. Your approved participant information explains known and anticipated reactions. Contact the research nurse at your baby’s local hospital if you suspect a reaction, but contact your baby’s local clinical service first when clinical advice is needed.
Study tools for every family
WheezeScan and chest-infection swabs
All participating parents receive a WheezeScan and a swab kit, with instructions and training from their local hospital research team.
Nasal and mouth swabs
If your baby becomes unwell with a chest infection, collect the nasal and mouth samples as instructed, package them using the supplied materials and send them directly to Cardiff.
Swab collection guide ↗WheezeScan
Use the WheezeScan provided to support recognition and recording of wheeze. It does not diagnose illness or replace assessment by your baby’s local clinical service.
WheezeScan guide ↗Optional substudies
Blood sampling or lung-function measurements may be offered separately at selected sites, with additional information and consent where required.
Travel and practical planning
Speak to the team before circumstances change
Check storage, transport, supply and contact arrangements in advance.
Update address, telephone and GP details promptly.
Request additional treatment before supplies are exhausted.
Confirm reimbursement eligibility before making study-related arrangements.
Practical questions
Check before guessing
Where exactly should the treatment be stored?
This must follow the current label and site-supplied instructions. The website deliberately does not provide a generic temperature because the approved instructions are authoritative.
Can treatment be given with other medicines or immunisations?
Do not change prescribed care or immunisations. Tell the research nurse at your baby’s local hospital about medicines and ask them any treatment-specific question.
What expenses are reimbursed?
Ask your local team before incurring costs. Reimbursement arrangements may depend on the activity and current approved study policy.
Who should we contact outside office hours?
Use the locally supplied contact sheet. The central BALLOON email is not an emergency or out-of-hours clinical service.
What if our contact details change?
Tell the local team promptly so that study supplies, follow-up and eventual results can reach you.
Can someone else give the spray?
Only a person trained according to the study instructions should administer it. Discuss other carers with your local team.
Keep your local contact sheet available
For any trial issue, contact your local hospital research nurse.
For clinical advice, contact your baby’s local clinical service. The central team can answer general, non-participant-specific questions by email.