The UK 22 Week Study

May 27, 2026 updated by: Imperial College London

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

In United Kingdom

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Not applicable (observational study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core Neonatal Outcomes - BPD
Time Frame: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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
Time Frame: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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
Time Frame: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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
Time Frame: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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
Time Frame: Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

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

Investigators

  • Study Director: Cheryl WS Battersby, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS 346626

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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