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.
調査の概要
詳細な説明
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
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Cheryl WS Battersby
- 電話番号：02075941862
- メール：c.battersby@imperial.ac.uk
研究連絡先のバックアップ
- 名前：Helen McDermott
- メール：h.mcdermott@imperial.ac.uk
研究場所
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-
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Aberdeen、イギリス
- 募集
- Neonatal Unit, Aberdeen Maternity Hospital
-
コンタクト：
- Via main study team
-
Ashford、イギリス
- 募集
- Neonatal Unit, William Harvey Hospital
-
コンタクト：
- Via main study team
-
Belfast、イギリス
- 募集
- Neonatal Unit, Royal Jubilee Maternity Hospital
-
コンタクト：
- Via main study team
-
Birmingham、イギリス
- 募集
- Neonatal Unit, Birmingham Heartlands Hospital (University Hospitals Birmingham)
-
コンタクト：
- Via main study team
-
Birmingham、イギリス
- 募集
- Neonatal Unit, Birmingham Women's and Children's Hospital
-
コンタクト：
- Via main study team
-
Bolton、イギリス
- 募集
- Neonatal Unit, Royal Bolton Hospital
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コンタクト：
- Via main study team
-
Bradford、イギリス
- 募集
- Neonatal Unit, Bradford Royal Infirmary
-
コンタクト：
- Via main study team
-
Bristol、イギリス
- 募集
- Neonatal Unit, Southmead Hospital
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コンタクト：
- Via main study team
-
Bristol、イギリス
- 募集
- Neonatal Unit, St Michael's Hospital
-
コンタクト：
- Via main study team
-
Burnley、イギリス
- 募集
- Neonatal Unit, Lancashire Women & Newborn Centre
-
コンタクト：
- Via main study team
-
Cambridge、イギリス
- 募集
- Neonatal Unit, Rosie Maternity Hospital
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コンタクト：
- Via main study team
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Chertsey、イギリス
- 募集
- Neonatal Unit, Ashford & St Peter's Hospital
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コンタクト：
- Via main study team
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Dundee、イギリス
- 募集
- Neonatal Unit, Ninewells Hospital
-
コンタクト：
- Via main study team
-
Edinburgh、イギリス
- 募集
- Neonatal Unit, Simpson Centre for Reproductive Health
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コンタクト：
- Via main study team
-
Gillingham、イギリス
- 募集
- Neonatal Unit, Medway Maritime Hospital
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コンタクト：
- Via main study team
-
Glasgow、イギリス
- 募集
- Neonatal Unit, Princess Royal Maternity Hospital
-
コンタクト：
- Via main study team
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Glasgow、イギリス
- 募集
- Royal Hospital for Children, Queen Elizabeth University Hospital
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コンタクト：
- Via main study team
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Hull、イギリス
- 募集
- Neonatal Unit, Hull Royal Infirmary
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コンタクト：
- Via main study team
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Leeds、イギリス
- 募集
- Leeds Neonatal Service
-
コンタクト：
- Via main study team
-
Leicester、イギリス
- 募集
- Neonatal Unit, Leicester Royal Infirmary
-
コンタクト：
- Via main study team
-
Liverpool、イギリス
- 募集
- Neonatal Surgical Unit, Alder Hey Children's Hospital
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コンタクト：
- Via main study team
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Liverpool、イギリス
- 募集
- Neonatal Unit, Liverpool Women's Hospital
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コンタクト：
- Via main study team
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London、イギリス
- 募集
- Imperial College
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コンタクト：
- Helen McDermott
- メール：h.mcdermott@imperial.ac.uk
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コンタクト：
- Cheryl WS Battersby
- メール：c.battersby@imperial.ac.uk
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London、イギリス
- 募集
- University College Hospital
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コンタクト：
- Via main study team
-
London、イギリス
- 募集
- Neonatal Unit, Chelsea and Westminster Hospital
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コンタクト：
- Via main study team
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London、イギリス
- 募集
- Neonatal Unit, Homerton University Hospital
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コンタクト：
- Via main study team
-
London、イギリス
- 募集
- Neonatal Unit, King's College Hospital
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コンタクト：
- Via main study team
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London、イギリス
- 募集
- Neonatal Unit, Queen Charlotte's and Chelsea Hospital
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London、イギリス
- 募集
- Neonatal Unit, Royal London Hospital
-
コンタクト：
- Via main study team
-
London、イギリス
- 募集
- Neonatal Unit, St George's Hospital
-
コンタクト：
- Via main study team
-
London、イギリス
- 募集
- Neonatal Surgical Unit, Great Ormond Street Hospital
-
コンタクト：
- Via study team
-
Luton、イギリス
- 募集
- Neonatal Unit, Luton & Dunstable Hospital
-
コンタクト：
- Via main study team
-
Manchester、イギリス
- 募集
- Neonatal Unit, St Mary's Hospital
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コンタクト：
- Via main study team
-
Newcastle upon Tyne、イギリス
- 募集
- Neonatal Unit, Royal Victoria Infirmary
-
コンタクト：
- Via main study team
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Norwich、イギリス
- 募集
- Neonatal Unit, Norfolk & Norwich University Hospitals
-
コンタクト：
- Via main study team
-
Nottingham、イギリス
- 募集
- Neonatal Unit, Queen's Medical Centre, University Hospital Nottingham
-
コンタクト：
- Via main study team
-
Oldham、イギリス
- 募集
- Neonatal Unit, Royal Oldham Hospital
-
コンタクト：
- Via main study team
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Oxford、イギリス
- 募集
- Neonatal Unit, John Radcliffe Hospital
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コンタクト：
- Via main study team
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Plymouth、イギリス
- 募集
- Neonatal Unit, Derriford Hospital
-
コンタクト：
- Via study team
-
Portsmouth、イギリス
- 募集
- Neonatal Unit, Queen Alexandra Hospital
-
コンタクト：
- Via main study team
-
Preston、イギリス
- 募集
- Neonatal Unit, Royal Preston Hospital
-
コンタクト：
- Via main study team
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Sheffield、イギリス
- 募集
- The Jessop Wing
-
コンタクト：
- Via main study team
-
Southampton、イギリス
- 募集
- Neonatal Unit, Princess Anne Hospital
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コンタクト：
- Via main study team
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Stoke-on-Trent、イギリス
- 募集
- Neonatal Unit, University Hospital of North Midlands
-
コンタクト：
- Via main study team
-
Upton、イギリス
- 募集
- Neonatal Unit, Arrowe Park Hospital
-
コンタクト：
- Via main study team
-
Wishaw、イギリス
- 募集
- Neonatal Unit, University Hospital Wishaw
-
コンタクト：
- Via main study team
-
Wolverhampton、イギリス
- 募集
- Neonatal Unit, New Cross Hospital
-
コンタクト：
- Via main study team
-
-
Teeside
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Middlesbrough、Teeside、イギリス
- 募集
- Neonatal Unit, James Cook University Hospital
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コンタクト：
- Via main study team
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-
Wales
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Cardiff、Wales、イギリス
- 募集
- Neonatal Unit, University Hospital of Wales
-
コンタクト：
- Via main study team
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Swansea、Wales、イギリス
- 募集
- Neonatal Unit, Singleton Hospital
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コンタクト：
- Via main study team
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
|
該当なし（観察研究）
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Survival to discharge from neonatal care
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Core Neonatal Outcomes - BPD
時間枠：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
時間枠：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
時間枠：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
時間枠：Infants from birth until death or discharge from neonatal care up to 50 weeks post-menstrual age
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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
時間枠：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
|
協力者と研究者
スポンサー
協力者
捜査官
- スタディディレクター：Cheryl WS Battersby、Imperial College London
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。