Surgical-PEARL protocol: a multicentre prospective cohort study exploring aetiology, management and outcomes for patients with congenital anomalies potentially requiring surgical intervention.

Autor:	Mires S; Translational Health Sciences, University of Bristol, Bristol, UK stuart.mires@bristol.ac.uk.; Women and Children's Health, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., de Jesus SE; Bristol Trials Centre, University of Bristol, Bristol, UK., Bamber AR; Translational Health Sciences, University of Bristol, Bristol, UK.; Pathology, North Bristol NHS Foundation Trust, Bristol, UK., Mumford A; Translational Health Sciences, University of Bristol, Bristol, UK.; Haematology, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Power B; CDH UK, Kings Lynn, UK., Bradshaw C; Women and Children's Health, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Lawlor D; MRC Integrative Epidemiology Unit, Department of Social Medicine, University of Bristol, Bristol, UK., Gill H; School of Physiology, Pharmacology and Neuroscience, University of Bristol, Bristol, UK.; Anaesthesia, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Luyt K; Translational Health Sciences, University of Bristol, Bristol, UK.; Women and Children's Health, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Baquedano M; Translational Health Sciences, University of Bristol, Bristol, UK., Overton T; Women and Children's Health, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Caputo M; Translational Health Sciences, University of Bristol, Bristol, UK.; Bristol Heart Institute, University of Bristol, Bristol, UK., Skerritt C; Women and Children's Health, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2022 Dec 09; Vol. 12 (12), pp. e066480. Date of Electronic Publication: 2022 Dec 09.
DOI:	10.1136/bmjopen-2022-066480
Abstrakt:	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. Competing Interests: Competing interests: DL has received support from Roche Diagnostics and Medtronic Ltd for research unrelated to this protocol. Other authors declare they have no conflicts. (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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