Approved participant documents
Authoritative information about participation, risks, rights and data use.
Demonstration resource hub — approved documents must be supplied and version-verified before launch
Preterm Lung Health Research
A clinical trial for babies born very prematurelyDocuments, videos and guides
BALLOON resource centre
One place for approved trial documents, practical videos, accessible formats and professional guidance.
How to use this page
Approved information and supporting guidance serve different purposes.
Practical supporting resources
Videos and web guides reinforce training but do not replace approved instructions.
Professional controlled documents
Used by appropriately trained and delegated trial staff.
For neonatal notice boards
BALLOON Trial parent recruitment poster
An A3 poster introducing BALLOON to families whose babies may be eligible. Local research teams can download and print it for appropriate neonatal settings.
Supporting material: the poster does not replace the approved Participant Information Sheet, eligibility assessment or consent discussion.
For parents and carers
Approved documents to read and keep
The current public BALLOON parent page provides explanatory text and videos, but not the controlled participant PDFs needed here. These cards will remain clearly marked until the approved source files and their metadata are supplied.
PDFAwaiting approved file
Participant information sheet
Complete approved information supporting consent.
PDFAwaiting approved file
Consent summary
Plain-language explanation of choices recorded during consent.
PDFAwaiting approved file
Privacy information
How personal information is collected, protected and retained.
PDFAwaiting approved file
Study treatment guide
Approved administration, storage and missed-dose instructions.
PDFLocal document
Contact and urgent-help card
Local contacts and reminder to use usual NHS emergency services.
PDFNot yet available
Results summary
A family-friendly summary will follow when results are available.
Watch and read
Practical video guides
Every video should ultimately include verified captions, a transcript and a downloadable illustrated guide.
▶01
Administration
Bactek spray guide
How to prepare and give the allocated oral spray safely.
Watch on YouTube ↗Transcript: awaiting verified text▶02
For every family
Swab collection guide
How parents collect nasal and mouth samples during a chest infection and send them directly to Cardiff.
Watch on YouTube ↗Transcript: awaiting verified text▶03
For every family
WheezeScan guide
How to use the WheezeScan provided to every participating family for study symptom reporting.
Watch on YouTube ↗Transcript: awaiting verified text▶04
Professional guide
Blood-sample collection
For trained professionals undertaking the blood substudy.
Watch on YouTube ↗Transcript: awaiting verified textFor trial teams
Controlled documents by function
Versions below reproduce the metadata currently displayed in the official professional library. Staff must still open that library and confirm the document has not been superseded before use.
Screening, consent and allocation
Screening and eligibilityv1.0 · 5 August 2024Verify in current library ↗Consentv1.1 · 21 January 2026Verify in current library ↗Randomisationv1.0 · 29 April 2024Verify in current library ↗Web randomisation data entryv1.0 · 13 February 2025Verify in current library ↗Parent trainingv1.0 · 4 June 2024Verify in current library ↗Treatment and data
Interventionv1.0 · 29 April 2024Verify in current library ↗IMP supply and accountabilityv1.0 · 13 August 2024Verify in current library ↗Data collectionv1.0 · 21 May 2024Verify in current library ↗YourResearch app data entryv2.1 · 17 July 2025Verify in current library ↗REDCap data entryv1.0 · 13 February 2025Verify in current library ↗Safety and completion
Safety and non-compliancev1.0 · 28 May 2024Verify in current library ↗Withdrawal and unblindingv1.0 · 28 May 2024Verify in current library ↗Sample shipmentv1.0 · 4 March 2024Verify in current library ↗Optional substudies
Lung-function substudyv1.0 · 9 October 2024Verify in current library ↗Blood-sampling substudyv2 · updated 24 June 2026Verify in current library ↗Information for everyone
Accessible and translated formats
Families should be able to understand the trial without avoidable language, sensory or literacy barriers.
High-contrast, large-text version.
Short sentences and supportive images.
Complete text alternative for every video.
Professionally translated and version controlled.
Accurately narrated core information.
Local interpretation and format support.
Before using a document
Five-point version check
If anything cannot be confirmed, return to the current online library.
- 1
Correct document and audience
- 2
Current version and approval date
- 3
Not marked superseded
- 4
Printed copy checked before use
- 5
Language and format needs considered
Content governance
Metadata for the final WordPress library
OwnerAudienceVersionApproval dateReview dateStatusLanguageAccessible format
Cannot access what you need?
For any trial issue, contact your local hospital research nurse.
For a broken website link or a general, non-participant-specific question, contact the central BALLOON team.