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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Born at 22+0-22+6 weeks gestational age

• Born in a NICU centre with neonatal team in attendance

• Or admitted to a NICU within first 72 hours of life if outborn

Locations
Other Locations
United Kingdom
Imperial College
RECRUITING
London
Neonatal Unit, Chelsea and Westminster Hospital
RECRUITING
London
Neonatal Unit, Homerton University Hospital
RECRUITING
London
Neonatal Unit, King's College Hospital
RECRUITING
London
Neonatal Unit, Queen Charlotte's and Chelsea Hospital
RECRUITING
London
Neonatal Unit, Royal London Hospital
RECRUITING
London
Neonatal Unit, St George's Hospital
RECRUITING
London
University College Hospital
RECRUITING
London
Contact Information
Primary
Cheryl WS Battersby
c.battersby@imperial.ac.uk
02075941862
Backup
Helen McDermott
h.mcdermott@imperial.ac.uk
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 100
Treatments
Babies born at 22 weeks in neonatal intensive care units in the UK
Attended to by neonatal team at birth or transferred into a NICU
Related Therapeutic Areas
Sponsors
Collaborators: Chelsea and Westminster NHS Foundation Trust, NeoTRIPs - British Association of Perinatal Medicine associated group of neonatal trainee-led research, education and QI network, CW+ Charity, Kids Intensive Care and Decision Support & Neonatal Transfer Service (KIDSNTS), Birmingham Women's and Children's NHS Foundation Trust
Leads: Imperial College London

This content was sourced from clinicaltrials.gov