Demonstration redesign — verify all procedures against current approved trial documents
Preterm Lung Health Research
A clinical trial for babies born very prematurelyFor healthcare professionals
Delivering BALLOON safely and consistently
Task-based guidance for neonatal, research, pharmacy, laboratory and trial-delivery teams.
At a glance
A randomised, double-blind, placebo-controlled trial
BALLOON is evaluating daily Bactek oral spray versus placebo for 12 months after hospital discharge in babies born before 30 weeks’ gestation.
Core trial workflow
From screening to completion
Select the task you need. The linked current guidance remains authoritative.
- 01
Screen and confirm eligibility
Use the current screening and eligibility guidance. Record screening according to the protocol and local approvals.
Screening & Eligibility ↗ - 02
Approach the family
Use a sensitive, non-pressured approach when the baby is clinically appropriate. Provide the current approved parent information.
Parent discussion resources ↗ - 03
Consent
Confirm capacity, opportunity for questions and completion of all required consent documentation before trial procedures.
Consent guidance ↗ - 04
Randomise
Complete eligibility and consent checks before accessing the secure randomisation service. Randomisation is for authorised staff only.
Open randomisation system ↗ - 05
Dispense and train
Follow current pharmacy, intervention and accountability guidance. Train parents in preparation, administration and storage.
Intervention guidance ↗ - 06
Follow up
Complete scheduled data collection and support families with treatment, reporting and study procedures.
Data collection guidance ↗ - 07
Safety and non-compliance
Assess clinical needs first, then complete protocol-defined safety reporting and manage deviations or missed treatment.
Safety guidance ↗ - 08
Withdrawal or unblinding
Document the family’s choices precisely. Emergency unblinding must follow the approved procedure.
Withdrawal guidance ↗
Trial systems
Use the correct system for each task
Access is role-dependent. Never share credentials or use another team member’s account.
CHaRT
Randomisation, consent and core trial processes
YourResearch
Participant-facing study data and app guidance
REDCap
Study data entry where specified
Sample pathway
Processing, packaging and shipment
Controlled documents
Guidance organised by function
Show version number, approval date and superseded status when these are connected to the live document library.
General
Screening and eligibilityCheck current version ↗InterventionCheck current version ↗Data collectionCheck current version ↗Safety and non-complianceCheck current version ↗Parent trainingCheck current version ↗Sample shipmentCheck current version ↗CHaRT
ConsentCheck current version ↗RandomisationCheck current version ↗Web randomisation data entryCheck current version ↗Withdrawal and unblindingCheck current version ↗IMP supply and accountabilityCheck current version ↗Family study procedures
Swab proceduresCheck current version ↗WheezeScan guidanceCheck current version ↗Substudies
Lung-function substudyCheck current version ↗Blood-sampling substudyCheck current version ↗Document-control rule
Do not rely on a locally saved or printed copy unless its version matches the current document library.
Family procedures and optional substudies
Make the distinction clear
All participating families receive a WheezeScan and swab kit. Blood sampling and lung-function measurements are separate, site-dependent substudies.
Swabs and WheezeScan
Train every family to use WheezeScan and to collect nasal and mouth samples when their baby develops a chest infection. Parents send the samples directly to Cardiff using the supplied materials and instructions.
Lung-function substudy
Where offered, follow the dedicated consent, measurement, calibration, acceptability and data-transfer guidance.
Blood substudy
Where offered, use the current consent, sampling video and guidance for timing, volumes, processing and shipment.
!
Safety first
Clinical care always takes priority.
Assess and treat an unwell baby according to usual clinical practice. Then determine whether expedited safety reporting, treatment interruption, protocol-deviation reporting or unblinding is required.
Supporting families
Consistency without pressure
Explain uncertainty, placebo allocation, study burden, optional elements and withdrawal choices clearly. Check understanding and allow time for questions.
Contacts and troubleshooting
Route questions to the right team
Protocol, eligibility, consent, withdrawals and general operational questions.
BALLOON@cardiff.ac.ukCheck the relevant system guidance first, then use the support route supplied to your site.
Use the current safety guidance and site-specific urgent contacts. Do not delay clinical care.
Use the current supply, storage, dispensing, accountability and temperature-excursion procedures.