Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chelsea and Westminster NHS Foundation Trust | OTHER |
| NeoTRIPs - British Association of Perinatal Medicine associated group of neonatal trainee-led research, education and QI network | UNKNOWN |
| CW+ Charity |
Not provided
Not provided
Not provided
Not provided
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.
Parents of eligible babies receive an information leaflet on how the pseudonymised data is used. A data collection team of trained clinical staff input the data (available in the notes) into a REDCap database.
Aims and Objectives
1. To describe and analyse the risk factors and clinical care for babies born at 22 weeks in UK neonatal intensive care units (NICUs)
Description:
4. Where babies die, to report the timing, cause of death, whether reorientation to comfort care took place and influencing factors or indications for redirection.
Time Frame: From admission until death or discharge from neonatal care
2. To describe unit approaches and equipment for 22 week babies across the UK
Description: To conduct a national survey across the NICUs and report i) the proportion of units and networks which have protocols for the care of babies born at 22 weeks. ii) Report similarities and differences in clinical care approaches. iii) Report common challenges faced by teams caring for babies born at 22 weeks
Time Frame: One-off unit questionnaire on entering the study
3. Explore wider hypotheses and feasibility of longer term monitoring of this cohort
Description: To explore associations between baby and clinical care factors and outcomes. To generate hypotheses, inform the design of future studies, support proof of concept and feasibility for a larger scale study or registry for 22-week babies in the UK
Time Frame: Duration of study and analysis
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable (observational study) | Other | Not applicable (observational study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Core Neonatal Outcomes - BPD | Bronchopulmonary Dysplasia at 36 weeks (Oxygen requirement) | Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age |
| Core Neonatal Outcomes - ROP |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
In United Kingdom
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheryl WS Battersby | Contact | 02075941862 | c.battersby@imperial.ac.uk | |
| Helen McDermott | Contact | h.mcdermott@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Cheryl WS Battersby | Imperial College London | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Unit, James Cook University Hospital | Recruiting | Middlesbrough | Teeside | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38027415 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
IPD will not be shared due to small numbers to prevent any potential identification and due to ethical approval limits
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: One-Off Variables Collected | Apr 17, 2026 |
Not provided
| Kids Intensive Care and Decision Support & Neonatal Transfer Service (KIDSNTS), Birmingham Women's and Children's NHS Foundation Trust | UNKNOWN |
Not provided
Not provided
Not provided
Retinopathy Of Prematurity requiring Treatment
| Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age |
| Core Neonatal Outcomes - Severe brain injury | Intraventricular haemorrhage grades 3-4, Periventricular Leucomalacia | Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age |
| Core Neonatal Outcomes - NEC | Necrotising Enterocolitis or Perforation (any cause) requiring surgical intervention | Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age |
| Core Neonatal Outcomes - LOS | Late-onset sepsis (culture positive) >72 hours of age | Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age |
| Neonatal Unit, University Hospital of Wales | Recruiting | Cardiff | Wales | United Kingdom |
|
| Neonatal Unit, Singleton Hospital | Recruiting | Swansea | Wales | United Kingdom |
|
| Neonatal Unit, Aberdeen Maternity Hospital | Recruiting | Aberdeen | United Kingdom |
|
| Neonatal Unit, William Harvey Hospital | Recruiting | Ashford | United Kingdom |
|
| Neonatal Unit, Royal Jubilee Maternity Hospital | Recruiting | Belfast | United Kingdom |
|
| Neonatal Unit, Birmingham Heartlands Hospital (University Hospitals Birmingham) | Recruiting | Birmingham | United Kingdom |
|
| Neonatal Unit, Birmingham Women's and Children's Hospital | Recruiting | Birmingham | United Kingdom |
|
| Neonatal Unit, Royal Bolton Hospital | Recruiting | Bolton | United Kingdom |
|
| Neonatal Unit, Bradford Royal Infirmary | Recruiting | Bradford | United Kingdom |
|
| Neonatal Unit, Southmead Hospital | Recruiting | Bristol | United Kingdom |
|
| Neonatal Unit, St Michael's Hospital | Recruiting | Bristol | United Kingdom |
|
| Neonatal Unit, Lancashire Women & Newborn Centre | Recruiting | Burnley | United Kingdom |
|
| Neonatal Unit, Rosie Maternity Hospital | Recruiting | Cambridge | United Kingdom |
|
| Neonatal Unit, Ashford & St Peter's Hospital | Recruiting | Chertsey | United Kingdom |
|
| Neonatal Unit, Ninewells Hospital | Recruiting | Dundee | United Kingdom |
|
| Neonatal Unit, Simpson Centre for Reproductive Health | Recruiting | Edinburgh | United Kingdom |
|
| Neonatal Unit, Medway Maritime Hospital | Recruiting | Gillingham | United Kingdom |
|
| Neonatal Unit, Princess Royal Maternity Hospital | Recruiting | Glasgow | United Kingdom |
|
| Royal Hospital for Children, Queen Elizabeth University Hospital | Recruiting | Glasgow | United Kingdom |
|
| Neonatal Unit, Hull Royal Infirmary | Recruiting | Hull | United Kingdom |
|
| Leeds Neonatal Service | Recruiting | Leeds | United Kingdom |
|
| Neonatal Unit, Leicester Royal Infirmary | Recruiting | Leicester | United Kingdom |
|
| Neonatal Surgical Unit, Alder Hey Children's Hospital | Recruiting | Liverpool | United Kingdom |
|
| Neonatal Unit, Liverpool Women's Hospital | Recruiting | Liverpool | United Kingdom |
|
| Imperial College | Recruiting | London | United Kingdom |
|
| Neonatal Surgical Unit, Great Ormond Street Hospital | Recruiting | London | United Kingdom |
|
| Neonatal Unit, Chelsea and Westminster Hospital | Recruiting | London | United Kingdom |
|
| Neonatal Unit, Homerton University Hospital | Recruiting | London | United Kingdom |
|
| Neonatal Unit, King's College Hospital | Recruiting | London | United Kingdom |
|
| Neonatal Unit, Queen Charlotte's and Chelsea Hospital | Recruiting | London | United Kingdom |
| Neonatal Unit, Royal London Hospital | Recruiting | London | United Kingdom |
|
| Neonatal Unit, St George's Hospital | Recruiting | London | United Kingdom |
|
| University College Hospital | Recruiting | London | United Kingdom |
|
| Neonatal Unit, Luton & Dunstable Hospital | Recruiting | Luton | United Kingdom |
|
| Neonatal Unit, St Mary's Hospital | Recruiting | Manchester | United Kingdom |
|
| Neonatal Unit, Royal Victoria Infirmary | Recruiting | Newcastle upon Tyne | United Kingdom |
|
| Neonatal Unit, Norfolk & Norwich University Hospitals | Recruiting | Norwich | United Kingdom |
|
| Neonatal Unit, Queen's Medical Centre, University Hospital Nottingham | Recruiting | Nottingham | United Kingdom |
|
| Neonatal Unit, Royal Oldham Hospital | Recruiting | Oldham | United Kingdom |
|
| Neonatal Unit, John Radcliffe Hospital | Recruiting | Oxford | United Kingdom |
|
| Neonatal Unit, Derriford Hospital | Recruiting | Plymouth | United Kingdom |
|
| Neonatal Unit, Queen Alexandra Hospital | Recruiting | Portsmouth | United Kingdom |
|
| Neonatal Unit, Royal Preston Hospital | Recruiting | Preston | United Kingdom |
|
| The Jessop Wing | Recruiting | Sheffield | United Kingdom |
|
| Neonatal Unit, Princess Anne Hospital | Recruiting | Southampton | United Kingdom |
|
| Neonatal Unit, University Hospital of North Midlands | Recruiting | Stoke-on-Trent | United Kingdom |
|
| Neonatal Unit, Arrowe Park Hospital | Recruiting | Upton | United Kingdom |
|
| Neonatal Unit, University Hospital Wishaw | Recruiting | Wishaw | United Kingdom |
|
| Neonatal Unit, New Cross Hospital | Recruiting | Wolverhampton | United Kingdom |
|
| Apr 17, 2026 |
| Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Daily Variables Collected D1-7 | Apr 17, 2026 | Apr 17, 2026 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: Weekly Variables | Apr 17, 2026 | Apr 17, 2026 | Prot_003.pdf |
| Prot | Yes | No | No | Study Protocol: Up-to-date protocol | Oct 21, 2025 | Mar 2, 2026 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Optional or Repeated Form Variables | Apr 17, 2026 | Apr 17, 2026 | Prot_004.pdf |
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided