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RECRUITING
NCT07616778

The UK 22 Week Study

Sponsor: Imperial College London

View on ClinicalTrials.gov

Summary

In the UK, babies born at 22 weeks of pregnancy have only been offered survival-focused care (sometimes called resuscitation or stabilisation) since 2019. Very few babies are born this early each year and sadly a lot of them do not survive. Therefore, healthcare teams don't have much information about this new population of tiny babies and there is much to learn about how they respond, the problems they face and the best way for intensive care units to look after them. This study aims to collect information available in babies' medical notes, analyse it and share learning to start improving this knowledge. There will be no changes to the babies' care, only observation of what happens. A small team of doctors and nurse practitioners who have/are looking after a baby, will put a small amount of selected information, without 'identifiers' such as the baby's name, date of birth or hospital number, onto a secure database platform at Imperial College London (a university). Researchers will analyse the information from all the babies around the UK together to look for trends and to describe common things that happen to them, as well as their outcomes. Parents will be made aware this information is being collected and used through a leaflet. It will not be possible to identify an individual baby in the results. The investigators are aiming for around 45 hospitals across the UK to participate. Babies born at 22 weeks gestation, who are attended to at birth by a neonatal team (or admitted) at an intensive care site over a 12-month period will be included. While collecting this information will not impact the babies included, it may help the treatment of babies born early in the future and give families more accurate information about what they might expect to happen.

Official title: Clinical Management and Short-Term Outcomes of Neonates Born at 22 Weeks in the UK (The 22 Week Study)

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-06-01

Completion Date

2027-12

Last Updated

2026-06-24

Healthy Volunteers

No

Interventions

OTHER

Not applicable (observational study)

Not applicable (observational study)

Locations (50)

Neonatal Unit, James Cook University Hospital

Middlesbrough, Teeside, United Kingdom

Neonatal Unit, University Hospital of Wales

Cardiff, Wales, United Kingdom

Neonatal Unit, Singleton Hospital

Swansea, Wales, United Kingdom

Neonatal Unit, Aberdeen Maternity Hospital

Aberdeen, United Kingdom

Neonatal Unit, William Harvey Hospital

Ashford, United Kingdom

Neonatal Unit, Royal Jubilee Maternity Hospital

Belfast, United Kingdom

Neonatal Unit, Birmingham Heartlands Hospital (University Hospitals Birmingham)

Birmingham, United Kingdom

Neonatal Unit, Birmingham Women's and Children's Hospital

Birmingham, United Kingdom

Neonatal Unit, Royal Bolton Hospital

Bolton, United Kingdom

Neonatal Unit, Bradford Royal Infirmary

Bradford, United Kingdom

Neonatal Unit, Southmead Hospital

Bristol, United Kingdom

Neonatal Unit, St Michael's Hospital

Bristol, United Kingdom

Neonatal Unit, Lancashire Women & Newborn Centre

Burnley, United Kingdom

Neonatal Unit, Rosie Maternity Hospital

Cambridge, United Kingdom

Neonatal Unit, Ashford & St Peter's Hospital

Chertsey, United Kingdom

Neonatal Unit, Ninewells Hospital

Dundee, United Kingdom

Neonatal Unit, Simpson Centre for Reproductive Health

Edinburgh, United Kingdom

Neonatal Unit, Medway Maritime Hospital

Gillingham, United Kingdom

Neonatal Unit, Princess Royal Maternity Hospital

Glasgow, United Kingdom

Royal Hospital for Children, Queen Elizabeth University Hospital

Glasgow, United Kingdom

Neonatal Unit, Hull Royal Infirmary

Hull, United Kingdom

Leeds Neonatal Service

Leeds, United Kingdom

Neonatal Unit, Leicester Royal Infirmary

Leicester, United Kingdom

Neonatal Surgical Unit, Alder Hey Children's Hospital

Liverpool, United Kingdom

Neonatal Unit, Liverpool Women's Hospital

Liverpool, United Kingdom

Imperial College

London, United Kingdom

Neonatal Surgical Unit, Great Ormond Street Hospital

London, United Kingdom

Neonatal Unit, Chelsea and Westminster Hospital

London, United Kingdom

Neonatal Unit, Homerton University Hospital

London, United Kingdom

Neonatal Unit, King's College Hospital

London, United Kingdom

Neonatal Unit, Queen Charlotte's and Chelsea Hospital

London, United Kingdom

Neonatal Unit, Royal London Hospital

London, United Kingdom

Neonatal Unit, St George's Hospital

London, United Kingdom

University College Hospital

London, United Kingdom

Neonatal Unit, Luton & Dunstable Hospital

Luton, United Kingdom

Neonatal Unit, St Mary's Hospital

Manchester, United Kingdom

Neonatal Unit, Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

Neonatal Unit, Norfolk & Norwich University Hospitals

Norwich, United Kingdom

Neonatal Unit, Queen's Medical Centre, University Hospital Nottingham

Nottingham, United Kingdom

Neonatal Unit, Royal Oldham Hospital

Oldham, United Kingdom

Neonatal Unit, John Radcliffe Hospital

Oxford, United Kingdom

Neonatal Unit, Derriford Hospital

Plymouth, United Kingdom

Neonatal Unit, Queen Alexandra Hospital

Portsmouth, United Kingdom

Neonatal Unit, Royal Preston Hospital

Preston, United Kingdom

The Jessop Wing

Sheffield, United Kingdom

Neonatal Unit, Princess Anne Hospital

Southampton, United Kingdom

Neonatal Unit, University Hospital of North Midlands

Stoke-on-Trent, United Kingdom

Neonatal Unit, Arrowe Park Hospital

Upton, United Kingdom

Neonatal Unit, University Hospital Wishaw

Wishaw, United Kingdom

Neonatal Unit, New Cross Hospital

Wolverhampton, United Kingdom