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The UK 22 Week Study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07616778
Enrollment
100
Registered
2026-06-01
Start date
2025-06-01
Completion date
2027-12-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature, Intensive Care, Neonatal, Neonatal and Perinatal Conditions

Keywords

Neonatal, extreme prematurity, observational

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.

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 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: 1. To determine whether management of infants born at 22 weeks align with British Association of Perinatal Medicine (BAPM) recommendations based on risk stratification 2. 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. 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

Interventions

Not applicable (observational study)

Sponsors

Imperial College London
Lead SponsorOTHER
Chelsea and Westminster NHS Foundation Trust
CollaboratorOTHER
NeoTRIPs - British Association of Perinatal Medicine associated group of neonatal trainee-led research, education and QI network
CollaboratorUNKNOWN
CW+ Charity
CollaboratorOTHER
Kids Intensive Care and Decision Support & Neonatal Transfer Service (KIDSNTS), Birmingham Women's and Children's NHS Foundation Trust
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Survival to discharge from neonatal careInfants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual ageSurvival to discharge from neonatal care

Secondary

MeasureTime frameDescription
Core Neonatal Outcomes - BPDInfants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual ageBronchopulmonary Dysplasia at 36 weeks (Oxygen requirement)
Core Neonatal Outcomes - ROPInfants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual ageRetinopathy Of Prematurity requiring Treatment
Core Neonatal Outcomes - Severe brain injuryInfants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual ageIntraventricular haemorrhage grades 3-4, Periventricular Leucomalacia
Core Neonatal Outcomes - NECInfants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual ageNecrotising Enterocolitis or Perforation (any cause) requiring surgical intervention
Core Neonatal Outcomes - LOSInfants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual ageLate-onset sepsis (culture positive) \>72 hours of age

Countries

United Kingdom

Contacts

CONTACTCheryl WS Battersby
c.battersby@imperial.ac.uk02075941862
CONTACTHelen McDermott
h.mcdermott@imperial.ac.uk
STUDY_DIRECTORCheryl WS Battersby

Imperial College London

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026