Surgical-PEARL protocol: a multicentre prospective cohort study exploring aetiology, management and outcomes for patients with congenital anomalies potentially requiring surgical intervention
Introduction Congenital anomalies affect over 2% of pregnancies. Surgical advances have reduced mortality and improved survival for patients with congenital anomalies potentially requiring surgical (CAPRS) intervention. However, our understanding of aetiology, diagnostic methods, optimal management,...
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| Format: | Article |
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BMJ Publishing Group
2022-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/12/e066480.full |
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| author | Clare Skerritt Massimo Caputo Andrew Mumford Karen Luyt Mai Baquedano Andrew R Bamber Catherine Bradshaw Deborah Lawlor Samantha E de Jesus Stuart Mires Beverley Power Hannah Gill Tim Overton |
| author_facet | Clare Skerritt Massimo Caputo Andrew Mumford Karen Luyt Mai Baquedano Andrew R Bamber Catherine Bradshaw Deborah Lawlor Samantha E de Jesus Stuart Mires Beverley Power Hannah Gill Tim Overton |
| author_sort | Clare Skerritt |
| collection | DOAJ |
| description | Introduction Congenital anomalies affect over 2% of pregnancies. Surgical advances have reduced mortality and improved survival for patients with congenital anomalies potentially requiring surgical (CAPRS) intervention. However, our understanding of aetiology, diagnostic methods, optimal management, outcomes and prognostication is limited. Existing birth cohorts have low numbers of individual heterogenous CAPRS. The Surgical Paediatric congEnital Anomalies Registry with Long term follow-up (Surgical-PEARL) study aims to establish a multicentre prospective fetal, child and biological parent cohort of CAPRS.Methods and analysis From 2022 to 2027, Surgical-PEARL aims to recruit 2500 patients with CAPRS alongside their biological mothers and fathers from up to 15 UK centres. Recruitment will be antenatal or postnatal dependent on diagnosis timing and presentation to a recruitment site. Routine clinical data including antenatal scans and records, neonatal intensive care unit (NICU) records, diagnostic and surgical data and hospital episode statistics will be collected. A detailed biobank of samples will include: parents’ blood and urine samples; amniotic fluid if available; children’s blood and urine samples on admission to NICU, perioperatively or if the child has care withdrawn or is transferred for extracorporeal membrane oxygenation; stool samples; and surplus surgical tissue. Parents will complete questionnaires including sociodemographic and health data. Follow-up outcome and questionnaire data will be collected for 5 years. Once established we will explore the potential of comparing findings in Surgical-PEARL to general population cohorts born in the same years and centres.Ethics and dissemination Ethical and health research authority approvals have been granted (IRAS Project ID: 302251; REC reference number 22/SS/0004). Surgical-PEARL is adopted onto the National Institute for Health Research Clinical Research Network portfolio. Findings will be disseminated widely through peer-reviewed publication, conference presentations and through patient organisations and newsletters.Trial registration number ISRCTN12557586. |
| format | Article |
| id | doaj-art-e336b2ee8a3c4b8699ffddb82bde5c87 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-e336b2ee8a3c4b8699ffddb82bde5c872025-08-20T02:57:08ZengBMJ Publishing GroupBMJ Open2044-60552022-12-01121210.1136/bmjopen-2022-066480Surgical-PEARL protocol: a multicentre prospective cohort study exploring aetiology, management and outcomes for patients with congenital anomalies potentially requiring surgical interventionClare Skerritt0Massimo Caputo1Andrew Mumford2Karen Luyt3Mai Baquedano4Andrew R Bamber5Catherine Bradshaw6Deborah Lawlor7Samantha E de Jesus8Stuart Mires9Beverley Power10Hannah Gill11Tim Overton12Women and Children`s Health, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UKDepartment of Paediatric Cardiac Surgery, Bristol Royal Hospital for Children, Bristol, UKSchool of Cellular and Molecular Medicine, Bristol Medical School, University of Bristol, Bristol, UKUniversity of Bristol, Bristol, UKTranslational Health Sciences, University of Bristol, Bristol, UK2 Cellular Pathology Department, Southmead Hospital, Bristol, UKWomen and Children`s Health, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UKMRC Integrative Epidemiology Unit, Department of Social Medicine, University of Bristol, Bristol, UKBristol Trials Centre, Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol, UKTranslational Health Sciences, University of Bristol, Bristol, UKCDH UK, Kings Lynn, UKSchool of Physiology, Pharmacology and Neuroscience, University of Bristol, Bristol, UKWomen and Children`s Health, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UKIntroduction Congenital anomalies affect over 2% of pregnancies. Surgical advances have reduced mortality and improved survival for patients with congenital anomalies potentially requiring surgical (CAPRS) intervention. However, our understanding of aetiology, diagnostic methods, optimal management, outcomes and prognostication is limited. Existing birth cohorts have low numbers of individual heterogenous CAPRS. The Surgical Paediatric congEnital Anomalies Registry with Long term follow-up (Surgical-PEARL) study aims to establish a multicentre prospective fetal, child and biological parent cohort of CAPRS.Methods and analysis From 2022 to 2027, Surgical-PEARL aims to recruit 2500 patients with CAPRS alongside their biological mothers and fathers from up to 15 UK centres. Recruitment will be antenatal or postnatal dependent on diagnosis timing and presentation to a recruitment site. Routine clinical data including antenatal scans and records, neonatal intensive care unit (NICU) records, diagnostic and surgical data and hospital episode statistics will be collected. A detailed biobank of samples will include: parents’ blood and urine samples; amniotic fluid if available; children’s blood and urine samples on admission to NICU, perioperatively or if the child has care withdrawn or is transferred for extracorporeal membrane oxygenation; stool samples; and surplus surgical tissue. Parents will complete questionnaires including sociodemographic and health data. Follow-up outcome and questionnaire data will be collected for 5 years. Once established we will explore the potential of comparing findings in Surgical-PEARL to general population cohorts born in the same years and centres.Ethics and dissemination Ethical and health research authority approvals have been granted (IRAS Project ID: 302251; REC reference number 22/SS/0004). Surgical-PEARL is adopted onto the National Institute for Health Research Clinical Research Network portfolio. Findings will be disseminated widely through peer-reviewed publication, conference presentations and through patient organisations and newsletters.Trial registration number ISRCTN12557586.https://bmjopen.bmj.com/content/12/12/e066480.full |
| spellingShingle | Clare Skerritt Massimo Caputo Andrew Mumford Karen Luyt Mai Baquedano Andrew R Bamber Catherine Bradshaw Deborah Lawlor Samantha E de Jesus Stuart Mires Beverley Power Hannah Gill Tim Overton Surgical-PEARL protocol: a multicentre prospective cohort study exploring aetiology, management and outcomes for patients with congenital anomalies potentially requiring surgical intervention BMJ Open |
| title | Surgical-PEARL protocol: a multicentre prospective cohort study exploring aetiology, management and outcomes for patients with congenital anomalies potentially requiring surgical intervention |
| title_full | Surgical-PEARL protocol: a multicentre prospective cohort study exploring aetiology, management and outcomes for patients with congenital anomalies potentially requiring surgical intervention |
| title_fullStr | Surgical-PEARL protocol: a multicentre prospective cohort study exploring aetiology, management and outcomes for patients with congenital anomalies potentially requiring surgical intervention |
| title_full_unstemmed | Surgical-PEARL protocol: a multicentre prospective cohort study exploring aetiology, management and outcomes for patients with congenital anomalies potentially requiring surgical intervention |
| title_short | Surgical-PEARL protocol: a multicentre prospective cohort study exploring aetiology, management and outcomes for patients with congenital anomalies potentially requiring surgical intervention |
| title_sort | surgical pearl protocol a multicentre prospective cohort study exploring aetiology management and outcomes for patients with congenital anomalies potentially requiring surgical intervention |
| url | https://bmjopen.bmj.com/content/12/12/e066480.full |
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