The UK 22 Week Study
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.
研究概览
详细说明
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:
- 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.
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
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Cheryl WS Battersby
- 电话号码：02075941862
- 邮箱：c.battersby@imperial.ac.uk
研究联系人备份
- 姓名：Helen McDermott
- 邮箱：h.mcdermott@imperial.ac.uk
学习地点
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-
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Aberdeen、英国
- 招聘中
- Neonatal Unit, Aberdeen Maternity Hospital
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接触：
- Via main study team
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Ashford、英国
- 招聘中
- Neonatal Unit, William Harvey Hospital
-
接触：
- Via main study team
-
Belfast、英国
- 招聘中
- Neonatal Unit, Royal Jubilee Maternity Hospital
-
接触：
- Via main study team
-
Birmingham、英国
- 招聘中
- Neonatal Unit, Birmingham Heartlands Hospital (University Hospitals Birmingham)
-
接触：
- Via main study team
-
Birmingham、英国
- 招聘中
- Neonatal Unit, Birmingham Women's and Children's Hospital
-
接触：
- Via main study team
-
Bolton、英国
- 招聘中
- Neonatal Unit, Royal Bolton Hospital
-
接触：
- Via main study team
-
Bradford、英国
- 招聘中
- Neonatal Unit, Bradford Royal Infirmary
-
接触：
- Via main study team
-
Bristol、英国
- 招聘中
- Neonatal Unit, Southmead Hospital
-
接触：
- Via main study team
-
Bristol、英国
- 招聘中
- Neonatal Unit, St Michael's Hospital
-
接触：
- Via main study team
-
Burnley、英国
- 招聘中
- Neonatal Unit, Lancashire Women & Newborn Centre
-
接触：
- Via main study team
-
Cambridge、英国
- 招聘中
- Neonatal Unit, Rosie Maternity Hospital
-
接触：
- Via main study team
-
Chertsey、英国
- 招聘中
- Neonatal Unit, Ashford & St Peter's Hospital
-
接触：
- Via main study team
-
Dundee、英国
- 招聘中
- Neonatal Unit, Ninewells Hospital
-
接触：
- Via main study team
-
Edinburgh、英国
- 招聘中
- Neonatal Unit, Simpson Centre for Reproductive Health
-
接触：
- Via main study team
-
Gillingham、英国
- 招聘中
- Neonatal Unit, Medway Maritime Hospital
-
接触：
- Via main study team
-
Glasgow、英国
- 招聘中
- Neonatal Unit, Princess Royal Maternity Hospital
-
接触：
- Via main study team
-
Glasgow、英国
- 招聘中
- Royal Hospital for Children, Queen Elizabeth University Hospital
-
接触：
- Via main study team
-
Hull、英国
- 招聘中
- Neonatal Unit, Hull Royal Infirmary
-
接触：
- Via main study team
-
Leeds、英国
- 招聘中
- Leeds Neonatal Service
-
接触：
- Via main study team
-
Leicester、英国
- 招聘中
- Neonatal Unit, Leicester Royal Infirmary
-
接触：
- Via main study team
-
Liverpool、英国
- 招聘中
- Neonatal Surgical Unit, Alder Hey Children's Hospital
-
接触：
- Via main study team
-
Liverpool、英国
- 招聘中
- Neonatal Unit, Liverpool Women's Hospital
-
接触：
- Via main study team
-
London、英国
- 招聘中
- Imperial College
-
接触：
- Helen McDermott
- 邮箱：h.mcdermott@imperial.ac.uk
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接触：
- Cheryl WS Battersby
- 邮箱：c.battersby@imperial.ac.uk
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London、英国
- 招聘中
- University College Hospital
-
接触：
- Via main study team
-
London、英国
- 招聘中
- Neonatal Unit, Chelsea and Westminster Hospital
-
接触：
- Via main study team
-
London、英国
- 招聘中
- Neonatal Unit, Homerton University Hospital
-
接触：
- Via main study team
-
London、英国
- 招聘中
- Neonatal Unit, King's College Hospital
-
接触：
- Via main study team
-
London、英国
- 招聘中
- Neonatal Unit, Queen Charlotte's and Chelsea Hospital
-
London、英国
- 招聘中
- Neonatal Unit, Royal London Hospital
-
接触：
- Via main study team
-
London、英国
- 招聘中
- Neonatal Unit, St George's Hospital
-
接触：
- Via main study team
-
London、英国
- 招聘中
- Neonatal Surgical Unit, Great Ormond Street Hospital
-
接触：
- Via study team
-
Luton、英国
- 招聘中
- Neonatal Unit, Luton & Dunstable Hospital
-
接触：
- Via main study team
-
Manchester、英国
- 招聘中
- Neonatal Unit, St Mary's Hospital
-
接触：
- Via main study team
-
Newcastle upon Tyne、英国
- 招聘中
- Neonatal Unit, Royal Victoria Infirmary
-
接触：
- Via main study team
-
Norwich、英国
- 招聘中
- Neonatal Unit, Norfolk & Norwich University Hospitals
-
接触：
- Via main study team
-
Nottingham、英国
- 招聘中
- Neonatal Unit, Queen's Medical Centre, University Hospital Nottingham
-
接触：
- Via main study team
-
Oldham、英国
- 招聘中
- Neonatal Unit, Royal Oldham Hospital
-
接触：
- Via main study team
-
Oxford、英国
- 招聘中
- Neonatal Unit, John Radcliffe Hospital
-
接触：
- Via main study team
-
Plymouth、英国
- 招聘中
- Neonatal Unit, Derriford Hospital
-
接触：
- Via study team
-
Portsmouth、英国
- 招聘中
- Neonatal Unit, Queen Alexandra Hospital
-
接触：
- Via main study team
-
Preston、英国
- 招聘中
- Neonatal Unit, Royal Preston Hospital
-
接触：
- Via main study team
-
Sheffield、英国
- 招聘中
- The Jessop Wing
-
接触：
- Via main study team
-
Southampton、英国
- 招聘中
- Neonatal Unit, Princess Anne Hospital
-
接触：
- Via main study team
-
Stoke-on-Trent、英国
- 招聘中
- Neonatal Unit, University Hospital of North Midlands
-
接触：
- Via main study team
-
Upton、英国
- 招聘中
- Neonatal Unit, Arrowe Park Hospital
-
接触：
- Via main study team
-
Wishaw、英国
- 招聘中
- Neonatal Unit, University Hospital Wishaw
-
接触：
- Via main study team
-
Wolverhampton、英国
- 招聘中
- Neonatal Unit, New Cross Hospital
-
接触：
- Via main study team
-
-
Teeside
-
Middlesbrough、Teeside、英国
- 招聘中
- Neonatal Unit, James Cook University Hospital
-
接触：
- Via main study team
-
-
Wales
-
Cardiff、Wales、英国
- 招聘中
- Neonatal Unit, University Hospital of Wales
-
接触：
- Via main study team
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Swansea、Wales、英国
- 招聘中
- Neonatal Unit, Singleton Hospital
-
接触：
- Via main study team
-
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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
|
不适用（观察性研究）
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Survival to discharge from neonatal care
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Core Neonatal Outcomes - BPD
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
合作者
调查人员
- 研究主任：Cheryl WS Battersby、Imperial College London
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.