NCT07616778

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Jun 2025

Typical duration for all trials

Geographic Reach
1 country

50 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jun 2025Dec 2027

Study Start

First participant enrolled

June 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

March 23, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

Neonatalextreme prematurityobservational

Outcome Measures

Primary Outcomes (1)

  • Survival to discharge from neonatal care

    Survival to discharge from neonatal care

    Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age

Secondary Outcomes (5)

  • Core Neonatal Outcomes - BPD

    Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age

  • Core Neonatal Outcomes - ROP

    Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age

  • Core Neonatal Outcomes - Severe brain injury

    Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age

  • Core Neonatal Outcomes - NEC

    Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age

  • Core Neonatal Outcomes - LOS

    Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age

Study Arms (1)

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

Other: Not applicable (observational study)

Interventions

Not applicable (observational study)

Babies born at 22 weeks in neonatal intensive care units in the UK

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In United Kingdom

You may qualify if:

  • 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

You may not qualify if:

  • Less than or more than 22 weeks gestation at birth
  • Known congenital anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (50)

Neonatal Unit, James Cook University Hospital

Middlesbrough, Teeside, United Kingdom

RECRUITING

Neonatal Unit, University Hospital of Wales

Cardiff, Wales, United Kingdom

RECRUITING

Neonatal Unit, Singleton Hospital

Swansea, Wales, United Kingdom

RECRUITING

Neonatal Unit, Aberdeen Maternity Hospital

Aberdeen, United Kingdom

RECRUITING

Neonatal Unit, William Harvey Hospital

Ashford, United Kingdom

RECRUITING

Neonatal Unit, Royal Jubilee Maternity Hospital

Belfast, United Kingdom

RECRUITING

Neonatal Unit, Birmingham Heartlands Hospital (University Hospitals Birmingham)

Birmingham, United Kingdom

RECRUITING

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

Birmingham, United Kingdom

RECRUITING

Neonatal Unit, Royal Bolton Hospital

Bolton, United Kingdom

RECRUITING

Neonatal Unit, Bradford Royal Infirmary

Bradford, United Kingdom

RECRUITING

Neonatal Unit, Southmead Hospital

Bristol, United Kingdom

RECRUITING

Neonatal Unit, St Michael's Hospital

Bristol, United Kingdom

RECRUITING

Neonatal Unit, Lancashire Women & Newborn Centre

Burnley, United Kingdom

RECRUITING

Neonatal Unit, Rosie Maternity Hospital

Cambridge, United Kingdom

RECRUITING

Neonatal Unit, Ashford & St Peter's Hospital

Chertsey, United Kingdom

RECRUITING

Neonatal Unit, Ninewells Hospital

Dundee, United Kingdom

RECRUITING

Neonatal Unit, Simpson Centre for Reproductive Health

Edinburgh, United Kingdom

RECRUITING

Neonatal Unit, Medway Maritime Hospital

Gillingham, United Kingdom

RECRUITING

Neonatal Unit, Princess Royal Maternity Hospital

Glasgow, United Kingdom

RECRUITING

Royal Hospital for Children, Queen Elizabeth University Hospital

Glasgow, United Kingdom

RECRUITING

Neonatal Unit, Hull Royal Infirmary

Hull, United Kingdom

RECRUITING

Leeds Neonatal Service

Leeds, United Kingdom

RECRUITING

Neonatal Unit, Leicester Royal Infirmary

Leicester, United Kingdom

RECRUITING

Neonatal Surgical Unit, Alder Hey Children's Hospital

Liverpool, United Kingdom

RECRUITING

Neonatal Unit, Liverpool Women's Hospital

Liverpool, United Kingdom

RECRUITING

Imperial College

London, United Kingdom

RECRUITING

Neonatal Surgical Unit, Great Ormond Street Hospital

London, United Kingdom

RECRUITING

Neonatal Unit, Chelsea and Westminster Hospital

London, United Kingdom

RECRUITING

Neonatal Unit, Homerton University Hospital

London, United Kingdom

RECRUITING

Neonatal Unit, King's College Hospital

London, United Kingdom

RECRUITING

Neonatal Unit, Queen Charlotte's and Chelsea Hospital

London, United Kingdom

RECRUITING

Neonatal Unit, Royal London Hospital

London, United Kingdom

RECRUITING

Neonatal Unit, St George's Hospital

London, United Kingdom

RECRUITING

University College Hospital

London, United Kingdom

RECRUITING

Neonatal Unit, Luton & Dunstable Hospital

Luton, United Kingdom

RECRUITING

Neonatal Unit, St Mary's Hospital

Manchester, United Kingdom

RECRUITING

Neonatal Unit, Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

RECRUITING

Neonatal Unit, Norfolk & Norwich University Hospitals

Norwich, United Kingdom

RECRUITING

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

Nottingham, United Kingdom

RECRUITING

Neonatal Unit, Royal Oldham Hospital

Oldham, United Kingdom

RECRUITING

Neonatal Unit, John Radcliffe Hospital

Oxford, United Kingdom

RECRUITING

Neonatal Unit, Derriford Hospital

Plymouth, United Kingdom

RECRUITING

Neonatal Unit, Queen Alexandra Hospital

Portsmouth, United Kingdom

RECRUITING

Neonatal Unit, Royal Preston Hospital

Preston, United Kingdom

RECRUITING

The Jessop Wing

Sheffield, United Kingdom

RECRUITING

Neonatal Unit, Princess Anne Hospital

Southampton, United Kingdom

RECRUITING

Neonatal Unit, University Hospital of North Midlands

Stoke-on-Trent, United Kingdom

RECRUITING

Neonatal Unit, Arrowe Park Hospital

Upton, United Kingdom

RECRUITING

Neonatal Unit, University Hospital Wishaw

Wishaw, United Kingdom

RECRUITING

Neonatal Unit, New Cross Hospital

Wolverhampton, United Kingdom

RECRUITING

Related Publications (1)

  • Smith LK, van Blankenstein E, Fox G, Seaton SE, Martinez-Jimenez M, Petrou S, Battersby C; MBRRACE-UK Perinatal Surveillance Group. Effect of national guidance on survival for babies born at 22 weeks' gestation in England and Wales: population based cohort study. BMJ Med. 2023 Nov 7;2(1):e000579. doi: 10.1136/bmjmed-2023-000579. eCollection 2023.

    PMID: 38027415BACKGROUND

Related Links

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Cheryl WS Battersby

    Imperial College London

    STUDY DIRECTOR

Central Study Contacts

Cheryl WS Battersby

CONTACT

Helen McDermott

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2026

First Posted

June 1, 2026

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to small numbers to prevent any potential identification and due to ethical approval limits

Locations