NCT03666767

Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries

Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries: A Multi-Centre, International, Prospective Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,850 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-centre, international, prospective cohort study of congenital anomalies to compare outcomes between LMICs and high-income countries (HICs) globally.

Detailed description

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.

Conditions

• Oesophageal Atresia
• Congenital Diaphragmatic Hernia
• Intestinal Atresia
• Gastroschisis
• Exomphalos
• Anorectal Malformation
• Hirschsprung Disease

Interventions

Type	Name	Description
OTHER	Comparisons will be made between LMICs and HICs	Countries will be defined as low, middle or high-income using the World Bank classification.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-06-30
• Completion: 2020-02-09
• First posted: 2018-09-12
• Last updated: 2020-02-24

Locations

1 site across 1 country: United Kingdom