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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not applicable (observational study)
Other interventionNot applicable (observational study)
Treatment groups
Trial outcomes
Primary outcomes
Survival to discharge from neonatal care
Survival to discharge from neonatal care
Secondary outcomes
Core Neonatal Outcomes - BPD
Bronchopulmonary Dysplasia at 36 weeks (Oxygen requirement)
Core Neonatal Outcomes - ROP
Retinopathy Of Prematurity requiring Treatment
Core Neonatal Outcomes - Severe brain injury
Intraventricular haemorrhage grades 3-4, Periventricular Leucomalacia
Core Neonatal Outcomes - NEC
Necrotising Enterocolitis or Perforation (any cause) requiring surgical intervention
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