Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries: A Multi-Centre, International, Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,850
- 试验地点
- 1
- 主要终点
- All-cause, in-hospital mortality
研究概览
简要总结
This study is a multi-centre, international, prospective cohort study of congenital anomalies to compare outcomes between LMICs and high-income countries (HICs) globally.
详细描述
Background: Congenital anomalies have risen to become the 5th leading cause of death in children under 5-years of age globally, yet limited literature exists, particularly from low- and middle-income countries (LMICs) where most of these deaths occur.
Aim: To undertake a multi-centre prospective cohort study of congenital anomalies to compare outcomes between LMICs and high-income countries (HICs) globally.
Methods: The Global PaedSurg Research Collaboration will be established consisting of children's surgical care providers from around the world to participate in the study; collaborators will be co-authors of resulting presentations and publication(s). Data will be collected on patients presenting primarily with seven congenital anomalies (oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation and Hirschsprung's disease) for a minimum of one month between Oct 2018 - April 2019. Anonymous data will be collected on patient demographics, clinical status, interventions and outcome. Data will be captured using the secure, online data collection tool REDCap.
The primary outcome will be all-cause in-hospital mortality and the secondary outcomes will be 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. P<0.05 will be deemed significant. Study approval will be sought from all participating centres. Funding has been granted by the Wellcome Trust.
Outcomes: The study aims to be the first large-scale, geographically comprehensive, multi-centre prospective cohort study of a selection of common congenital anomalies to define current management and outcomes globally. Results will be used to aid advocacy and global health prioritisation and inform future interventional studies aimed at improving outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any neonate, infant or child under the age of 16-years, presenting for the first time, with one of the study conditions can be included in the study.
- •Children who have NOT previously received any surgery for their condition.
- •Children who have received basic resuscitative and supportive care for their condition at a different healthcare facility and then been transferred to the study centre.
- •Patients presenting primarily with one of the study conditions who receive palliative care or no care must be included within the study to reflect true outcomes.
排除标准
- •Any neonate, infant or child with one of the study conditions who has previously received surgery (including a stoma) for their condition
- •If they have recently received surgery for their condition, were discharged and then represented with a complication of the surgery during the study period they should NOT be included in the study.
结局指标
主要结局
All-cause, in-hospital mortality
时间窗: Mortality whilst in hospital during primary admission, up to a maximum of 30-days following primary intervention or 30-days following presentation for those who do not receive an intervention and are still in hospital.
This will include all patients in the study, both those who did not receive an intervention and those that did. For patient's hospitalised for over 30-days following primary intervention, a 30-day post-primary intervention mortality rate will be utilised. For patients who do not receive a primary intervention (conservative generic ward care only) but remain alive and hospitalised at 30-days following primary admission will have this time point used for recording their mortality status for the primary outcome.
次要结局
- Surgical site-infection(Occurring within 30-days of primary intervention)
- Wound dehiscence(Occurring within 30-days of primary intervention)
- Need for re-intervention(Occurring within 30-days of primary intervention)
- Condition specific complications(Occurring within 30-days of primary intervention)
- Condition specific outcome variables(Occurring within 30-days of primary intervention)
- Length of hospital stay(Maximum 30-days post-intervention or following presentation for those who do not receive an intervention)
- 30-day post primary intervention mortality(Death within 30-days of primary intervention or 30-days of presentation in those who do not receive an intervention)
- Ventilation requirement(Occurring within 30-days of primary intervention or admission for those not receiving an intervention)
- Time to first enteral feed(Occurring within 30-days of primary intervention or admission for those not receiving an intervention)
- Time to full enteral feeds(Occurring within 30-days of primary intervention or admission for those not receiving an intervention)
- Parenteral nutrition requirement(Occurring within 30-days of primary intervention or admission for those not receiving an intervention)
研究者
Miss Naomi Wright
Miss Naomi Wright
King's College London