RecruitingInterventional

Evaluating the clinical and cost effectiveness of breathing support treatment types in infants under 12 months of age with acute bronchiolitis

Bronchiolitis is a common winter chest infection in babies that can make breathing difficult. Many babies admitted to hospital need extra breathing support. Doctors currently use three safe, standard NHS treatments: moist standard oxygen, high-flow oxygen, and continuous positive airway pressure (CPAP). However, it is not clear which one works best or helps babies go home sooner. The BACHb trial is taking place in 50 NHS hospitals across England to find out. Babies with moderate breathing troubles will be randomly assigned to receive either moist oxygen or high-flow oxygen. Babies with more severe breathing problems will receive either high-flow oxygen or CPAP. Researchers will measure how quickly babies recover and leave hospital, as well as their comfort and parents' views. The goal is to improve national guidelines so that all unwell babies receive the most effective care.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

1,508

Start

01 Sep 2023

Estimated completion

31 Mar 2027

Bronchiolitis

What is this study about?

Bronchiolitis is a common chest infection caused by a virus. In the UK, it leads to nearly 30,000 hospital stays for babies each year. It causes the small airways in the lungs to swell and fill with mucus, making it harder for babies to breathe and feed. While many babies get better with simple oxygen through small nasal tubes, others need extra breathing machines to help them rest and recover.

At the moment, NHS doctors use different types of breathing support. These include standard moist oxygen, high-flow oxygen (which gently warms and speeds up airflow), and CPAP (a mask or nasal prong system that keeps the airways open with light pressure). High-flow oxygen has become very popular in recent years, but it requires special equipment and staff time. Doctors still do not have clear proof showing whether it actually helps babies go home any faster than the other treatments.

This clinical trial aims to give doctors clear answers. By comparing these treatments side by side in over 1,500 babies, researchers want to see which option is best at shortening hospital stays, keeping babies comfortable, and easing worries for parents. The results will help create clearer NHS guidelines for infant care in the future.

Key takeaways

Compares three standard NHS breathing supports for babies under 12 months with bronchiolitis.
Aims to discover which treatment helps babies recover fastest and leave hospital sooner.
All treatments being tested are safe, standard options already used in UK hospitals.
The medical team can adjust or change your baby's treatment at any time to keep them safe.
Participation happens during the hospital stay with no extra check-ups required afterwards.

Who may be eligible?

This study is open to babies under 12 months old who are staying in hospital with acute bronchiolitis and need extra breathing support.

Babies are grouped by how hard they are working to breathe. Those with moderate symptoms who are not improving on standard low-flow oxygen will be placed in one group. Babies with severe breathing difficulties, such as very rapid breathing or deep chest pulling, will be placed in another group.

Babies cannot take part if they need an immediate emergency breathing tube, have long pauses in their breathing, or have facial conditions that make fitting nasal prongs difficult. Babies who were already using breathing machines at home before getting sick are also not eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Your baby is under 12 months old.
Your baby is currently admitted to hospital with bronchiolitis.
Your baby needs extra breathing support beyond simple low-flow oxygen.
Your baby does not need an immediate emergency breathing tube or ventilator.
Your baby does not normally use a breathing machine at home.

Answer every question to see your result.

What does participation involve?

Taking part takes place entirely during your baby's normal hospital stay. A computer will randomly pick which breathing support treatment your baby starts with. Doctors and nurses will watch your baby closely, just as they would with normal NHS care. If your baby's breathing does not improve or gets worse, the medical team can change the treatment at any time. Staff will record how long your baby needs oxygen and how quickly they are ready to go home. You will also be asked about your baby's comfort and your own experience. Once your baby leaves the hospital, participation is complete, with no extra hospital visits needed.

Potential risks and benefits

There is no direct medical benefit guaranteed to your baby, but taking part will help doctors learn the best ways to care for babies with bronchiolitis in the future. All breathing treatments used in the study are standard, proven NHS options with known safety records. The study does not introduce untested medicines. The main consideration is that your baby's initial breathing device is chosen by random computer selection rather than the ward doctor. You have the right to decline or withdraw from the study at any time without giving a reason, and this will never affect the quality of your baby's care.

Locations (25)

NHS Lothian
Approximate
Edinburgh, Scotland
University Hospitals of Leicester NHS Trust
City only
Leicester, England
University Hospitals Bristol and Weston NHS Foundation Trust
City only
Bristol, England
University Hospital Southampton NHS Foundation Trust
City only
Southampton, England
NHS Grampian
Approximate
Aberdeen, Scotland
Imperial College Healthcare NHS Trust
Unverified
London, England
South Tyneside and Sunderland NHS Foundation Trust
Unverified
Sunderland, England
Belfast Health and Social Care Trust
Unverified
Belfast, Northern Ireland
Barking, Havering and Redbridge University Hospitals NHS Trust
Unverified
Romford, England
South Tees Hospitals NHS Foundation Trust
Unverified
Middlesbrough, England
Bradford Teaching Hospitals NHS Foundation Trust
Unverified
Bradford, England
Frimley Health NHS Foundation Trust
Unverified
Camberley, England

Common questions

What is bronchiolitis?

Bronchiolitis is a common viral chest infection that affects babies under one year of age, causing coughing, wheezing, and difficulty breathing.

Is this an experimental drug trial?

No. The study does not use experimental drugs. It compares three breathing machines that NHS hospitals already use every day.

Can the doctor change my baby's treatment if they do not improve?

Yes. Your baby's safety always comes first. The clinical team can change or increase breathing support at any point if needed.

Will taking part keep my baby in hospital longer?

No. Your baby will be discharged as soon as the medical team agrees they are well enough to go home safely.

Will we be paid for taking part?

No, there is no payment for taking part, as the study takes place during your baby's routine hospital admission.

How to find out more

Richard Cleaver

r.cleaver@imperial.ac.uk +44 7999 044627 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.