The UK 22 Week Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorImperial College London

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Less than or more than 22 weeks gestation at birth

Known congenital anomaly

Trial population

In United Kingdom

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Not applicable (observational study)

    Other intervention

    Not applicable (observational study)

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Babies born at 22 weeks in neonatal intensive care units in the UK1 intervention

Trial outcomes

Primary outcomes

1

Survival to discharge from neonatal care

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

Secondary outcomes

1

Core Neonatal Outcomes - BPD

Bronchopulmonary Dysplasia at 36 weeks (Oxygen requirement)

Time frame
Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
2

Core Neonatal Outcomes - ROP

Retinopathy Of Prematurity requiring Treatment

Time frame
Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
3

Core Neonatal Outcomes - Severe brain injury

Intraventricular haemorrhage grades 3-4, Periventricular Leucomalacia

Time frame
Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
4

Core Neonatal Outcomes - NEC

Necrotising Enterocolitis or Perforation (any cause) requiring surgical intervention

Time frame
Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College London

Lead sponsor

Chelsea and Westminster NHS Foundation Trust

Collaborator

NeoTRIPs - British Association of Perinatal Medicine associated group of neonatal trainee-led research, education and QI network

Collaborator

CW+ Charity

Collaborator

Kids Intensive Care and Decision Support & Neonatal Transfer Service (KIDSNTS), Birmingham Women's and Children's NHS Foundation Trust

Collaborator