Outcome monitoring and risk stratification after cardiac procedure in neonates, infants, children and young adults born with congenital heart disease: protocol for a multicentre prospective cohort study (Children OMACp).

Autor:	Baquedano M; Translational Health Sciences, University of Bristol, Bristol, UK mai.baquedano@bristol.ac.uk.; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., de Jesus SE; Translational Health Sciences, University of Bristol, Bristol, UK., Rapetto F; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Murphy GJ; Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Unit in Cardiovascular Medicine, NIHR Leicester Biomedical Research Centre Cardiovascular Diseases, Leicester, East Midlands, UK., Angelini G; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.; Bristol Medical School, University of Bristol, Bristol, UK., Benedetto U; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Caldas P; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Srivastava PK; Imperial College London, London, UK., Uzun O; Cardiff and Vale NHS Trust, Cardiff, UK., Luyt K; Bristol Medical School, University of Bristol, Bristol, UK.; NICU, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, Avon, UK., Gonzalez Corcia C; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Taliotis D; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Stoica S; Bristol Royal Hospital for Children, Bristol, UK., Lawlor DA; Bristol Medical School, University of Bristol, Bristol, UK.; MRC Integrative Epidemiology Unit, University of Bristol, Bristol, UK., Bamber AR; Bristol Medical School, University of Bristol, Bristol, UK.; North Bristol NHS Trust, Westbury on Trym, Bristol, UK., Perry A; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Skeffington KL; Bristol Heart Institute, University of Bristol, Bristol, UK., Omeje I; University Hospitals of Leicester NHS Trust, Leicester, UK., Pappachan J; PICU, Southampton Children's Hospital, Southampton, UK., Mumford AD; Department of Haematology, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK., Coward RJM; Translational Health Sciences, University of Bristol, Bristol, UK., Kenny D; Children's Health Ireland at Crumlin, Dublin, Crumlin, Ireland., Caputo M; Translational Health Sciences, University of Bristol, Bristol, UK.; Bristol Heart Institute, University of Bristol, Bristol, UK.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 Aug 08; Vol. 13 (8), pp. e071629. Date of Electronic Publication: 2023 Aug 08.
DOI:	10.1136/bmjopen-2023-071629
Abstrakt:	Introduction: Congenital heart disease (CHD) represents the most common birth defect, affecting from 0.4% to 1.2% of children born in developed countries. The survival of these patients has increased significantly, but CHD remains one of the major causes of neonatal and childhood death. The aetiology of CHD is complex, with some evidence of both genetic and environmental causes. However, there is still lack of knowledge regarding modifiable risk factors and molecular and genetic mechanisms underlying the development of CHD. This study aims to develop a prospective cohort of patients undergoing cardiac procedures that will bring together routinely collected clinical data and biological samples from patients and their biological mothers, in order to investigate risk factors and predictors of postoperative-outcomes, as well as better understanding the effect of the surgical intervention on the early and long-term outcomes. Methods and Analysis: Children OMACp (OMACp, outcome monitoring after cardiac procedure in congenital heart disease) is a multicentre, prospective cohort study recruiting children with CHD undergoing a cardiac procedure. The study aims to recruit 3000 participants over 5 years (2019-2024) across multiple UK sites. Routine clinical data will be collected, as well as participant questionnaires collecting sociodemographic, NHS resource use and quality of life data. Biological samples (blood, urine and surgical waste tissue from patients, and blood and urine samples from biological mothers) will be collected where consent has been obtained. Follow-up outcome and questionnaire data will be collected for 5 years. Ethics and Dissemination: The study was approved by the London-Brent Research Ethics Committee on 30 July 2019 (19/SW/0113). Participants (or their parent/guardian if under 16 years of age) must provide informed consent prior to being recruited into the study. Mothers who wish to take part must also provide informed consent prior to being recruited. The study is sponsored by University Hospitals Bristol and Weston Foundation Trust and is managed by the University of Bristol. Children OMACp is adopted onto the National Institute for Health Research Clinical Research Network portfolio. Findings will be disseminated through peer-reviewed publications, presentation at conference, meetings and through patient organisations and newsletters. Trial Registration Number: ISRCTN17650644. Competing Interests: Competing interests: DL has received support from Medtronic and Roche Diagnostics for research unrelated to this publication. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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