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.
연구 개요
상세 설명
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
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Cheryl WS Battersby
- 전화번호: 02075941862
- 이메일: c.battersby@imperial.ac.uk
연구 연락처 백업
- 이름: Helen McDermott
- 이메일: h.mcdermott@imperial.ac.uk
연구 장소
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-
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Aberdeen, 영국
- 모병
- Neonatal Unit, Aberdeen Maternity Hospital
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연락하다:
- Via main study team
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Ashford, 영국
- 모병
- Neonatal Unit, William Harvey Hospital
-
연락하다:
- Via main study team
-
Belfast, 영국
- 모병
- Neonatal Unit, Royal Jubilee Maternity Hospital
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연락하다:
- Via main study team
-
Birmingham, 영국
- 모병
- Neonatal Unit, Birmingham Heartlands Hospital (University Hospitals Birmingham)
-
연락하다:
- Via main study team
-
Birmingham, 영국
- 모병
- Neonatal Unit, Birmingham Women's and Children's Hospital
-
연락하다:
- Via main study team
-
Bolton, 영국
- 모병
- Neonatal Unit, Royal Bolton Hospital
-
연락하다:
- Via main study team
-
Bradford, 영국
- 모병
- Neonatal Unit, Bradford Royal Infirmary
-
연락하다:
- Via main study team
-
Bristol, 영국
- 모병
- Neonatal Unit, Southmead Hospital
-
연락하다:
- Via main study team
-
Bristol, 영국
- 모병
- Neonatal Unit, St Michael's Hospital
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연락하다:
- Via main study team
-
Burnley, 영국
- 모병
- Neonatal Unit, Lancashire Women & Newborn Centre
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연락하다:
- Via main study team
-
Cambridge, 영국
- 모병
- Neonatal Unit, Rosie Maternity Hospital
-
연락하다:
- Via main study team
-
Chertsey, 영국
- 모병
- Neonatal Unit, Ashford & St Peter's Hospital
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연락하다:
- Via main study team
-
Dundee, 영국
- 모병
- Neonatal Unit, Ninewells Hospital
-
연락하다:
- Via main study team
-
Edinburgh, 영국
- 모병
- Neonatal Unit, Simpson Centre for Reproductive Health
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연락하다:
- Via main study team
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Gillingham, 영국
- 모병
- Neonatal Unit, Medway Maritime Hospital
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연락하다:
- Via main study team
-
Glasgow, 영국
- 모병
- Neonatal Unit, Princess Royal Maternity Hospital
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연락하다:
- Via main study team
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Glasgow, 영국
- 모병
- Royal Hospital for Children, Queen Elizabeth University Hospital
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연락하다:
- Via main study team
-
Hull, 영국
- 모병
- Neonatal Unit, Hull Royal Infirmary
-
연락하다:
- Via main study team
-
Leeds, 영국
- 모병
- Leeds Neonatal Service
-
연락하다:
- Via main study team
-
Leicester, 영국
- 모병
- Neonatal Unit, Leicester Royal Infirmary
-
연락하다:
- Via main study team
-
Liverpool, 영국
- 모병
- Neonatal Surgical Unit, Alder Hey Children's Hospital
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연락하다:
- Via main study team
-
Liverpool, 영국
- 모병
- Neonatal Unit, Liverpool Women's Hospital
-
연락하다:
- Via main study team
-
London, 영국
- 모병
- Imperial College
-
연락하다:
- Helen McDermott
- 이메일: h.mcdermott@imperial.ac.uk
-
연락하다:
- Cheryl WS Battersby
- 이메일: c.battersby@imperial.ac.uk
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London, 영국
- 모병
- University College Hospital
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연락하다:
- Via main study team
-
London, 영국
- 모병
- Neonatal Unit, Chelsea and Westminster Hospital
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연락하다:
- Via main study team
-
London, 영국
- 모병
- Neonatal Unit, Homerton University Hospital
-
연락하다:
- Via main study team
-
London, 영국
- 모병
- Neonatal Unit, King's College Hospital
-
연락하다:
- Via main study team
-
London, 영국
- 모병
- Neonatal Unit, Queen Charlotte's and Chelsea Hospital
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London, 영국
- 모병
- Neonatal Unit, Royal London Hospital
-
연락하다:
- Via main study team
-
London, 영국
- 모병
- Neonatal Unit, St George's Hospital
-
연락하다:
- Via main study team
-
London, 영국
- 모병
- Neonatal Surgical Unit, Great Ormond Street Hospital
-
연락하다:
- Via study team
-
Luton, 영국
- 모병
- Neonatal Unit, Luton & Dunstable Hospital
-
연락하다:
- Via main study team
-
Manchester, 영국
- 모병
- Neonatal Unit, St Mary's Hospital
-
연락하다:
- Via main study team
-
Newcastle upon Tyne, 영국
- 모병
- Neonatal Unit, Royal Victoria Infirmary
-
연락하다:
- Via main study team
-
Norwich, 영국
- 모병
- Neonatal Unit, Norfolk & Norwich University Hospitals
-
연락하다:
- Via main study team
-
Nottingham, 영국
- 모병
- Neonatal Unit, Queen's Medical Centre, University Hospital Nottingham
-
연락하다:
- Via main study team
-
Oldham, 영국
- 모병
- Neonatal Unit, Royal Oldham Hospital
-
연락하다:
- Via main study team
-
Oxford, 영국
- 모병
- Neonatal Unit, John Radcliffe Hospital
-
연락하다:
- Via main study team
-
Plymouth, 영국
- 모병
- Neonatal Unit, Derriford Hospital
-
연락하다:
- Via study team
-
Portsmouth, 영국
- 모병
- Neonatal Unit, Queen Alexandra Hospital
-
연락하다:
- Via main study team
-
Preston, 영국
- 모병
- Neonatal Unit, Royal Preston Hospital
-
연락하다:
- Via main study team
-
Sheffield, 영국
- 모병
- The Jessop Wing
-
연락하다:
- Via main study team
-
Southampton, 영국
- 모병
- Neonatal Unit, Princess Anne Hospital
-
연락하다:
- Via main study team
-
Stoke-on-Trent, 영국
- 모병
- Neonatal Unit, University Hospital of North Midlands
-
연락하다:
- Via main study team
-
Upton, 영국
- 모병
- Neonatal Unit, Arrowe Park Hospital
-
연락하다:
- Via main study team
-
Wishaw, 영국
- 모병
- Neonatal Unit, University Hospital Wishaw
-
연락하다:
- Via main study team
-
Wolverhampton, 영국
- 모병
- Neonatal Unit, New Cross Hospital
-
연락하다:
- Via main study team
-
-
Teeside
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Middlesbrough, Teeside, 영국
- 모병
- Neonatal Unit, James Cook University Hospital
-
연락하다:
- Via main study team
-
-
Wales
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Cardiff, Wales, 영국
- 모병
- Neonatal Unit, University Hospital of Wales
-
연락하다:
- Via main study team
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Swansea, Wales, 영국
- 모병
- Neonatal Unit, Singleton Hospital
-
연락하다:
- Via main study team
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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
|
해당 없음(관찰 연구)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Survival to discharge from neonatal care
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Core Neonatal Outcomes - BPD
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Cheryl WS Battersby, Imperial College London
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .