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NCT Number: NCT07616778

The UK 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.

Recruiting

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Neonatal Unit, James Cook University Hospital, Middlesbrough, Teeside, United Kingdom

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not applicable (Observational Study)

Other

Not applicable (observational study)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Cheryl WS Battersby

CONTACT

[email protected]

02075941862

Helen McDermott

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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