The UK 22 Week Study

Official title

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

Overview

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

• Other Not applicable (observational study)
  Not applicable (observational study)

Primary outcome measures

• 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 outcome measures (5)

• Core Neonatal Outcomes - BPD [Time frame: 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]
• 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]
• Core Neonatal Outcomes - NEC [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United Kingdom · 50 centers

• Neonatal Unit, James Cook University Hospital — Middlesbrough
• Neonatal Unit, University Hospital of Wales — Cardiff
• Neonatal Unit, Singleton Hospital — Swansea
• Neonatal Unit, Aberdeen Maternity Hospital — Aberdeen
• Neonatal Unit, William Harvey Hospital — Ashford
• Neonatal Unit, Royal Jubilee Maternity Hospital — Belfast
• Neonatal Unit, Birmingham Heartlands Hospital (University Hospitals Birmingham) — Birmingham
• Neonatal Unit, Birmingham Women's and Children's Hospital — Birmingham
• … and 42 more centers

Publications

• Smith LK, van Blankenstein E, Fox G, Seaton SE, Martinez-Jimenez M, Petrou S, Battersby C; MBRRACE-UK Perinatal Surveillance Group. Effect of national guidance on survival for babies born at 22 weeks' gestation in England and Wales: population based cohort study. BMJ Med. 2023 Nov 7;2(1):e000579. doi: 10.1136/bmjmed-2023-000579. eCollection 2023. PMID 38027415

Identifiers

NCT: NCT07616778 · IRAS 346626

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗