| Title: |
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) |
| Authors: |
Baquedano, Mai; de Jesus, Samantha E; Rapetto, Filippo; Murphy, Gavin J; Angelini, Gianni; Benedetto, Umberto; Caldas, Patricia; Srivastava, Prashant K; Uzun, Orhan; Luyt, Karen; Gonzalez Corcia, Cecilia; Taliotis, Demetris; Stoica, Serban; Lawlor, Deborah A; Bamber, Andrew R; Perry, Alison; Skeffington, Katie L; Omeje, Ikenna; Pappachan, John; Mumford, Andrew D; Coward, Richard J M; Kenny, Damien; Caputo, Massimo |
| Source: |
Baquedano, M, de Jesus, S E, Rapetto, F, Murphy, G J, Angelini, G, Benedetto, U, Caldas, P, Srivastava, P K, Uzun, O, Luyt, K, Gonzalez Corcia, C, Taliotis, D, Stoica, S, Lawlor, D A, Bamber, A R, Perry, A, Skeffington, K L, Omeje, I, Pappachan, J, Mumford, A D, Coward, R J M, Kenny, D & Caputo, M 2023, '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)', BMJ Open, vol. 13, no. 8, e071629. https://doi.org/10.1136/bmjopen-2023-071629 |
| Publication Year: |
2023 |
| Collection: |
University of Bristol: Bristol Reserach |
| Subject Terms: |
/dk/atira/pure/core/keywords/heart_SRI; name=Bristol Heart Institute; Infant; Newborn; Pregnancy; Female; Humans; Child; Young Adult; Prospective Studies; Quality of Life; Parturition; Heart Defects; Congenital/surgery; Risk Assessment; Multicenter Studies as Topic |
| Description: |
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 ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/37553192; info:eu-repo/semantics/altIdentifier/hdl/https://hdl.handle.net/1983/d05096bc-d637-4eb2-859d-607918911e72 |
| DOI: |
10.1136/bmjopen-2023-071629 |
| Availability: |
https://hdl.handle.net/1983/d05096bc-d637-4eb2-859d-607918911e72; https://research-information.bris.ac.uk/en/publications/d05096bc-d637-4eb2-859d-607918911e72; https://doi.org/10.1136/bmjopen-2023-071629 |
| Rights: |
info:eu-repo/semantics/openAccess ; http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.8CA9C6B2 |
| Database: |
BASE |