Extreme Prematurity - Less Than 28 WeeksNCT07616778
The UK 22 Week Study
An observational study of Extreme Prematurity - Less Than 28 Weeks and Infant, Extremely Premature, run by Imperial College London at 50 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature, Neonatal and Perinatal Conditions
- What is being tested?
- Not applicable (observational study)
- How many people
- 100 participants
- Where
- 50 sitesUnited Kingdom
- Study dates
- 1 Jun 2025to Dec 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In United Kingdom
Who may be able to join
- 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
Who cannot join
- Less than or more than 22 weeks gestation at birth
- Known congenital anomaly
Trial locations and contacts
50 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Helen McDermott contact
50 sites in 1 country
United Kingdom50 sites, 50 recruiting
- Recruiting
Neonatal Unit, Aberdeen Maternity Hospital
Aberdeen
Via main study team
- Recruiting
Neonatal Unit, William Harvey Hospital
Ashford
Via main study team
- Recruiting
Neonatal Unit, Royal Jubilee Maternity Hospital
Belfast
Via main study team
- Recruiting
Neonatal Unit, Birmingham Heartlands Hospital (University Hospitals Birmingham)
Birmingham
Via main study team
- Recruiting
Neonatal Unit, Birmingham Women's and Children's Hospital
Birmingham
Via main study team
- Recruiting
Neonatal Unit, Royal Bolton Hospital
Bolton
Via main study team
- Recruiting
Neonatal Unit, Bradford Royal Infirmary
Bradford
Via main study team
- Recruiting
Neonatal Unit, Southmead Hospital
Bristol
Via main study team
- Recruiting
Neonatal Unit, St Michael's Hospital
Bristol
Via main study team
- Recruiting
Neonatal Unit, Lancashire Women & Newborn Centre
Burnley
Via main study team
- Recruiting
Neonatal Unit, Rosie Maternity Hospital
Cambridge
Via main study team
- Recruiting
Neonatal Unit, University Hospital of Wales
Cardiff, Wales
Via main study team
- Recruiting
Neonatal Unit, Ashford & St Peter's Hospital
Chertsey
Via main study team
- Recruiting
Neonatal Unit, Ninewells Hospital
Dundee
Via main study team
- Recruiting
Neonatal Unit, Simpson Centre for Reproductive Health
Edinburgh
Via main study team
- Recruiting
Neonatal Unit, Medway Maritime Hospital
Gillingham
Via main study team
- Recruiting
Neonatal Unit, Princess Royal Maternity Hospital
Glasgow
Via main study team
- Recruiting
Royal Hospital for Children, Queen Elizabeth University Hospital
Glasgow
Via main study team
- Recruiting
Neonatal Unit, Hull Royal Infirmary
Hull
Via main study team
- Recruiting
Leeds Neonatal Service
Leeds
Via main study team
- Recruiting
Neonatal Unit, Leicester Royal Infirmary
Leicester
Via main study team
- Recruiting
Neonatal Surgical Unit, Alder Hey Children's Hospital
Liverpool
Via main study team
- Recruiting
Neonatal Unit, Liverpool Women's Hospital
Liverpool
Via main study team
- Recruiting
Imperial College
London
Cheryl WS Battersby, c.battersby@imperial.ac.uk
Helen McDermott, h.mcdermott@imperial.ac.uk
- Recruiting
Neonatal Surgical Unit, Great Ormond Street Hospital
London
Via study team
- Recruiting
Neonatal Unit, Chelsea and Westminster Hospital
London
Via main study team
- Recruiting
Neonatal Unit, Homerton University Hospital
London
Via main study team
- Recruiting
Neonatal Unit, King's College Hospital
London
Via main study team
- Recruiting
Neonatal Unit, Queen Charlotte's and Chelsea Hospital
London
- Recruiting
Neonatal Unit, Royal London Hospital
London
Via main study team
- Recruiting
Neonatal Unit, St George's Hospital
London
Via main study team
- Recruiting
University College Hospital
London
Via main study team
- Recruiting
Neonatal Unit, Luton & Dunstable Hospital
Luton
Via main study team
- Recruiting
Neonatal Unit, St Mary's Hospital
Manchester
Via main study team
- Recruiting
Neonatal Unit, James Cook University Hospital
Middlesbrough, Teeside
Via main study team
- Recruiting
Neonatal Unit, Royal Victoria Infirmary
Newcastle upon Tyne
Via main study team
- Recruiting
Neonatal Unit, Norfolk & Norwich University Hospitals
Norwich
Via main study team
- Recruiting
Neonatal Unit, Queen's Medical Centre, University Hospital Nottingham
Nottingham
Via main study team
- Recruiting
Neonatal Unit, Royal Oldham Hospital
Oldham
Via main study team
- Recruiting
Neonatal Unit, John Radcliffe Hospital
Oxford
Via main study team
- Recruiting
Neonatal Unit, Derriford Hospital
Plymouth
Via study team
- Recruiting
Neonatal Unit, Queen Alexandra Hospital
Portsmouth
Via main study team
- Recruiting
Neonatal Unit, Royal Preston Hospital
Preston
Via main study team
- Recruiting
The Jessop Wing
Sheffield
Via main study team
- Recruiting
Neonatal Unit, Princess Anne Hospital
Southampton
Via main study team
- Recruiting
Neonatal Unit, University Hospital of North Midlands
Stoke-on-Trent
Via main study team
- Recruiting
Neonatal Unit, Singleton Hospital
Swansea, Wales
Via main study team
- Recruiting
Neonatal Unit, Arrowe Park Hospital
Upton
Via main study team
- Recruiting
Neonatal Unit, University Hospital Wishaw
Wishaw
Via main study team
- Recruiting
Neonatal Unit, New Cross Hospital
Wolverhampton
Via main study team
About this study
Official title: Clinical Management and Short-Term Outcomes of Neonates Born at 22 Weeks in the UK (The 22 Week Study)
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.
Read more
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.
Read the detailed description
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
- To describe and analyse the risk factors and clinical care for babies born at 22 weeks in UK neonatal intensive care units (NICUs)
Description:
- To determine whether management of infants born at 22 weeks align with British Association of Perinatal Medicine (BAPM) recommendations based on risk stratification
- To report the proportion of infants receiving interventions in the following areas of clinical care at a baby and network level: a. Delivery room stabilisation b. Respiratory \& cardiovascular c. Neurological d. Gastroenterological \& Surgical e. Renal f. Haematology g. Infection h. Skin, thermal management, monitoring 3.To report the short-term outcomes (survival or death) following neonatal care. Additional standard neonatal outcomes to be reported.
- 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
- 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
- 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
- Conditions
- Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature, Neonatal and Perinatal Conditions, Intensive Care, Neonatal
- Being tested
- Not applicable (observational study)
- Keywords
- Neonatal, extreme prematurity, observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable (observational study)Other
Not applicable (observational study)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Not applicable (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to discharge from neonatal care
Survival to discharge from neonatal care
Measured: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Secondary outcomes (5)
Core Neonatal Outcomes - BPD
Bronchopulmonary Dysplasia at 36 weeks (Oxygen requirement)
Measured: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Core Neonatal Outcomes - ROP
Retinopathy Of Prematurity requiring Treatment
Measured: 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
Measured: 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
Measured: 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
Measured: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extreme Prematurity - Less Than 28 WeeksStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Cheryl WS Battersby, Study director, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616778
- Sponsor's protocol ID
- IRAS 346626
- Status last verified
- Jun 2026
- First submitted
- 23 Mar 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to small numbers to prevent any potential identification and due to ethical approval limits
Publications
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.
PubMed 38027415
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Management and Short-Term Outcomes of Neonates Born at 22 Weeks in the UK (The 22 Week Study)
- ClinicalTrials.gov ID
- NCT07616778
- Acronym / sponsor ID
- IRAS 346626
- Conditions
- Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature, Neonatal and Perinatal Conditions, Intensive Care, Neonatal
- Keywords
- Neonatal, extreme prematurity, observational
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- 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
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- To describe and analyse the risk factors and clinical care for babies born at 22 weeks in UK neonatal intensive care units (NICUs)
Description:
- To determine whether management of infants born at 22 weeks align with British Association of Perinatal Medicine (BAPM) recommendations based on risk stratification
- To report the proportion of infants receiving interventions in the following areas of clinical care at a baby and network level: a. Delivery room stabilisation b. Respiratory \& cardiovascular c. Neurological d. Gastroenterological \& Surgical e. Renal f. Haematology g. Infection h. Skin, thermal management, monitoring 3.To report the short-term outcomes (survival or death) following neonatal care. Additional standard neonatal outcomes to be reported.
- 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
- 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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Babies born at 22 weeks in neonatal intensive care units in the UK | – | Other: Not applicable (observational study)Attended to by neonatal team at birth or transferred into a NICU |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In United Kingdom
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Less than or more than 22 weeks gestation at birth
- Known congenital anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable (observational study)Not applicable (observational study) | Other | Babies born at 22 weeks in neonatal intensive care units in the UK |
Primary outcome
Survival to discharge from neonatal care
Time frame: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Survival to discharge from neonatal care
5 secondary outcomes
Core Neonatal Outcomes - BPD
Time frame: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Core Neonatal Outcomes - ROP
Time frame: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Core Neonatal Outcomes - Severe brain injury
Time frame: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Core Neonatal Outcomes - NEC
Time frame: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Core Neonatal Outcomes - LOS
Time frame: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 38027415Smith 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared due to small numbers to prevent any potential identification and due to ethical approval limits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helen McDermott contact
Cheryl WS Battersby study director
Imperial College London
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extreme Prematurity - Less Than 28 Weeks and Infant, Extremely Premature, run by Imperial College London at 50 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheryl WS Battersby (02075941862, c.battersby@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival to discharge from neonatal care (time frame: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07616778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.