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Preterm Lung Health Research
A clinical trial for babies born very prematurely
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A UK-wide clinical trial

Could an oral spray help protect babies born very prematurely from chest infections?

BALLOON is investigating whether a daily oral spray called Bactek can reduce chest infections in babies born before 30 weeks of pregnancy.

I’m a parent or carer →I’m a health professional

✓ Taking part is voluntary. Your baby’s usual NHS care will not be affected.

Parent gently holding a sleeping baby at home after neonatal care
Supporting little lungs after neonatal care
♡For parents & carersA clear guide to deciding and taking part→+For health professionalsEligibility, randomisation and resources→iAbout the researchProtocol, team, funding and progress→

Why BALLOON?

Babies born very early need better protection for their developing lungs.

Babies born before 30 weeks have lungs and immune systems that are still developing. After discharge, some develop chest infections requiring medical attention or hospital care.

Bactek contains inactivated bacterial components that cannot reproduce or cause bacterial infection. It is intended to stimulate immune responses, but we do not yet know whether it prevents chest infections. That is why this trial is needed.

Hear directly from the BALLOON community

The trial, explained by our lead researcher and parents.

These short videos introduce why BALLOON matters and offer a family perspective on the study.

FROM THE RESEARCH TEAM

Professor Sailesh Kotecha explains BALLOON

Why the study is needed and how it aims to protect the developing lungs of babies born very prematurely.

Watch on YouTube ↗
FROM PARENTS

Parents share their perspective

A family view of BALLOON, helping other parents understand the study and what participation means.

Watch on YouTube ↗
See all practical video guides →

An honest comparison

Two groups. One important question.

A computer allocates each baby by chance to one of two groups. This randomisation makes the comparison fair and reliable.

Neither families nor their clinical team normally know which spray a baby receives until the study finishes. All babies continue usual care.

Understand randomisation and placebo →
•GROUP ABactek sprayDaily for 12 months
or
•GROUP BPlacebo sprayDaily for 12 months

What taking part involves

Your family’s BALLOON journey

The research nurse at your baby’s local hospital guides you throughout and is your contact for any trial-related issue.

  1. 01

    A conversation

    The research team explains the study, checks eligibility and answers your questions.

  2. 02

    Your choice

    You have time to decide. Taking part is voluntary and will not affect your baby’s NHS care.

  3. 03

    Allocation by chance

    A computer allocates Bactek or placebo. Neither you nor the clinical team normally knows which.

  4. 04

    At home

    You give the study spray daily for 12 months after discharge, supported by the BALLOON team.

  5. 05

    Follow-up

    You record breathing symptoms and healthcare contacts, use the WheezeScan provided, and collect nasal and mouth swabs if your baby develops a chest infection. Parents send the samples directly to Cardiff. Optional substudies may also be offered.

♡

You remain in control. You can stop the spray or withdraw from follow-up at any time.

If your baby is unwell

Contact your baby’s local clinical service.

Use the clinical contact provided by your baby’s hospital, or contact their neonatal team, GP or NHS 111. In an emergency, call 999. The BALLOON email is not a clinical service.

Visit NHS 111 online ↗

Questions families ask

Clear answers before you decide

Will my baby definitely receive Bactek?

No. Babies are allocated by chance to Bactek or placebo. This is the only reliable way to find out whether Bactek works.

What is a placebo?

It looks and is given in the same way as Bactek but has no active ingredients. All babies continue to receive usual NHS care.

Can we change our minds?

Yes. You can stop at any time without giving a reason, and your baby’s care will not be affected.

What if my baby becomes unwell?

Contact your baby’s local clinical service for advice. This may be their neonatal team, GP, NHS 111 or emergency services. The study email is not a clinical service.

Ask the BALLOON team

Clinical teams

Everything you need to deliver BALLOON

Quick access for authorised trial staff, organised around the task.

01Check eligibilityScreening checklist and criteria02Consent & randomiseCurrent guidance and secure system03Support familiesTraining videos and parent guides04Safety & follow-upReporting, withdrawal and data entry

Randomisation and operational systems are for authorised trial staff only.

How families join BALLOON

Eligible families are approached in their baby’s hospital.

BALLOON recruits babies while they are receiving neonatal care at a participating hospital. If your baby may be eligible, a member of the local research team will speak with you, explain the study and answer your questions.

Together, families move research forward

Recruitment progress

Live recruitment figures are temporarily unavailable.

View the recruitment dashboard →

Parent health resource

Keeping your premature baby well after going home

A Guide to Chest Infections. Practical information about reducing infection risk, RSV protection, caring for coughs and colds, and recognising when to seek help.

Read the guide →Download PDF
UK edition | September 2026
Parent gently holding a premature baby at home.

Preterm Lung Health Research

Connected research from neonatal care through later life

AZTEC, BALLOON and RHiNO form a linked programme investigating how to prevent, understand and treat respiratory disease following preterm birth.

NEONATAL PERIODAZTECAzithromycin, neonatal lung disease and follow-up researchVisit AZTEC ↗
AFTER DISCHARGEBALLOONPreventing chest infections during a vulnerable period of lung developmentYou are here
CHILDHOOD TO LATER LIFERHiNOUnderstanding PLD phenotypes, trajectories and treatmentVisit RHiNO ↗