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).
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).
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DOI：
10.1136/bmjopen-2023-071629
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发表时间：
2023-08-08
期刊：
影响因子：
2.9
通讯作者：
Caputo, Massimo
中科院分区：
文献类型：
--
作者：
Baquedano, Mai;de Jesus, Samantha E.;Rapetto, Filippo;Murphy, Gavin J.;Angelini, Gianni;Benedetto, Umberto;Caldas, Patricia;Srivastava, Prashant K.;Uzun, Orhan;Luyt, Karen;Corcia, Cecilia Gonzalez;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
先天性心脏病（CHD）是最常见的出生缺陷，影响发达国家出生的0.4%至1.2%的儿童。这些患者的存活率显著提高，但CHD仍然是新生儿和儿童死亡的主要原因之一。冠心病的病因是复杂的，有一些证据表明遗传和环境原因。然而，仍然缺乏知识，可改变的危险因素和分子和遗传机制的发展冠心病。本研究旨在开发一个前瞻性队列，将常规收集的患者及其生物学母亲的临床数据和生物学样本汇集在一起，以研究术后结局的风险因素和预测因素，以及更好地了解手术干预对早期和长期结局的影响。儿童OMACp（OMACp，先天性心脏病心脏手术后结局监测）是一项多中心、前瞻性队列研究，招募了接受心脏手术的CHD儿童。该研究的目标是在5年内（2019-2024年）在多个英国研究中心招募3000名参与者。将收集常规临床数据，以及收集社会人口统计、NHS资源使用和生活质量数据的参与者问卷。在获得知情同意的情况下，将采集生物样本（患者的血液、尿液和手术废物组织，以及生物学母亲的血液和尿液样本）。将收集5年的随访结果和问卷调查数据。本研究于2019年7月30日获得伦敦-布伦特研究伦理委员会的批准（19/SW/0113）。受试者（或其父母/监护人，如果未满16岁）必须在入组研究前提供知情同意书。希望参加的母亲也必须在被招募之前提供知情同意。这项研究由布里斯托大学医院和韦斯顿基金会信托基金赞助，由布里斯托大学管理。儿童OMACp被纳入国家卫生研究所临床研究网络组合。调查结果将通过同行评审的出版物，在会议上的演讲，会议和通过病人组织和通讯传播。ISRCTN17650644。
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. 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. 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. ISRCTN17650644.
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影响因子：
30.8
作者：
Cordell, Heather J.;Bentham, Jamie;Topf, Ana;Zelenika, Diana;Heath, Simon;Mamasoula, Chrysovalanto;Cosgrove, Catherine;Blue, Gillian;Granados-Riveron, Javier;Setchfield, Kerry;Thornborough, Chris;Breckpot, Jeroen;Soemedi, Rachel;Martin, Ruairidh;Rahman, Thahira J.;Hall, Darroch;van Engelen, Klaartje;Moorman, Antoon F. M.;Zwinderman, Aelko H.;Barnett, Phil;Koopmann, Tamara T.;Adriaens, Michiel E.;Varro, Andras;George, Alfred L., Jr.;dos Remedios, Christobal;Bishopric, Nanette H.;Bezzina, Connie R.;O'Sullivan, John;Gewillig, Marc;Bu'Lock, Frances A.;Winlaw, David;Bhattacharya, Shoumo;Devriendt, Koen;Brook, J. David;Mulder, Barbara J. M.;Mital, Seema;Postma, Alex V.;Lathrop, G. Mark;Farrall, Martin;Goodship, Judith A.;Keavney, Bernard D.
通讯作者：
Keavney, Bernard D.
影响因子：
8
作者：
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通讯作者：
Erickson, JD
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37.8
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MITCHELL, SC;KORONES, SB;BERENDES, HW
通讯作者：
BERENDES, HW
影响因子：
37.8
作者：
Marelli, Ariane J.;Mackie, Andrew S.;Pilote, Louise
通讯作者：
Pilote, Louise
影响因子：
1.9
作者：
Lalani, Seema R.;Belmont, John W.
通讯作者：
Belmont, John W.