King's Centre for Global Health and Health Partnerships, King's College London, London, UK
BMJ Open. 2019 Sep 3;9(8):e030452. doi: 10.1136/bmjopen-2019-030452.
Congenital anomalies are the fifth leading cause of death in children <5 years of age globally, contributing an estimated half a million deaths per year. Very limited literature exists from low and middle income countries (LMICs) where most of these deaths occur. The Global PaedSurg Research Collaboration aims to undertake the first multicentre, international, prospective cohort study of a selection of common congenital anomalies comparing management and outcomes between low, middle and high income countries (HICs) globally.
The Global PaedSurg Research Collaboration consists of surgeons, paediatricians, anaesthetists and allied healthcare professionals involved in the surgical care of children globally. Collaborators will prospectively collect observational data on consecutive patients presenting for the first time, with one of seven common congenital anomalies (oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation and Hirschsprung's disease).Patient recruitment will be for a minimum of 1 month from October 2018 to April 2019 with a 30-day post-primary intervention follow-up period. Anonymous data will be collected on patient demographics, clinical status, interventions and outcomes using REDCap. Collaborators will complete a survey regarding the resources and facilities for neonatal and paediatric surgery at their centre.The primary outcome is all-cause in-hospital mortality. Secondary outcomes include the occurrence of post-operative complications. Chi-squared analysis will be used to compare mortality between LMICs and HICs. Multilevel, multivariate logistic regression analysis will be undertaken to identify patient-level and hospital-level factors affecting outcomes with adjustment for confounding factors.
At the host centre, this study is classified as an audit not requiring ethical approval. All participating collaborators have gained local approval in accordance with their institutional ethical regulations. Collaborators will be encouraged to present the results locally, nationally and internationally. The results will be submitted for open access publication in a peer reviewed journal.
NCT03666767.
先天性畸形是全球 5 岁以下儿童死亡的第五大主要原因，每年估计造成 50 万人死亡。这些死亡大多发生在中低收入国家（LMICs），但相关文献非常有限。全球小儿外科研讨协作组织旨在开展第一项多中心、国际前瞻性队列研究，选择一些常见先天性畸形进行研究，在全球范围内比较低、中、高收入国家（HICs）的管理和结局。
全球小儿外科研讨协作组织由参与全球儿童外科护理的外科医生、儿科医生、麻醉师和相关医疗保健专业人员组成。协作人员将前瞻性地收集连续患者的观察数据，这些患者首次出现以下 7 种常见先天性畸形之一（食管闭锁、先天性膈疝、肠闭锁、腹裂、脐膨出、肛门直肠畸形和先天性巨结肠）。患者招募将从 2018 年 10 月至 2019 年 4 月持续至少 1 个月，并在主要干预后 30 天进行随访。使用 REDCap 收集患者人口统计学、临床状态、干预措施和结局的匿名数据。协作人员将完成一份关于其中心新生儿和小儿外科技能资源和设施的调查。主要结局是全因住院死亡率。次要结局包括术后并发症的发生。将使用卡方检验比较中低收入国家和高收入国家的死亡率。将进行多水平、多变量逻辑回归分析，以确定影响结局的患者和医院水平因素，并进行混杂因素调整。
在主办中心，这项研究被归类为不需要伦理批准的审计。所有参与协作的人员均根据其机构伦理法规获得了当地批准。协作人员将被鼓励在当地、全国和国际上展示研究结果。研究结果将提交给同行评审期刊进行开放获取出版。
NCT03666767。
