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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

2026-06-15

Healthy Volunteers

No

Interventions

OTHER

Not applicable (observational study)

Not applicable (observational study)

Locations (8)

Imperial College

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