Abstract
Background: Gastroschisis is associated with less than 4% mortality in high-income countries and over 90% mortality in many tertiary paediatric surgery centres across sub-Saharan Africa (SSA). The aim of this trial is to develop, implement and prospectively evaluate an interventional bundle to reduce mortality from gastroschisis in seven tertiary paediatric surgery centres across SSA. Methods: A hybrid type-2 effectiveness-implementation, pre-post study design will be utilised. Using current literature an evidence-based, low-technology interventional bundle has been developed. A systematic review, qualitative study and Delphi process will provide further evidence to optimise the interventional bundle and implementation strategy. The interventional bundle has core components, which will remain consistent across all sites, and adaptable components, which will be determined through in-country co-development meetings. Pre- and post-intervention data will be collected on clinical, service delivery and implementation outcomes for 2-years at each site. The primary clinical outcome will be all-cause, in-hospital mortality. Secondary outcomes include the occurrence of a major complication, length of hospital stay and time to full enteral feeds. Service delivery outcomes include time to hospital and primary intervention, and adherence to the pre-hospital and in-hospital protocols. Implementation outcomes are acceptability, adoption, appropriateness, feasibility, fidelity, coverage, cost and sustainability. Pre- and post-intervention clinical outcomes will be compared using Chi-squared analysis, unpaired t-test and/or Mann-Whitney Utest. Time-series analysis will be undertaken using Statistical Process Control to identify significant trends and shifts in outcome overtime. Multivariate logistic regression analysis will be used to identify clinical and implementation factors affecting outcome with adjustment for confounders. Outcome: This will be the first multi-centre interventional study to our knowledge aimed at reducing mortality from gastroschisis in low-resource settings. If successful, detailed evaluation of both the clinical and implementation components of the study will allow sustainability in the study sites and further scale-up. Registration: ClinicalTrials.gov Identifier NCT03724214.
Highlights
The problem Gastroschisis, one of the commonest congenital anomalies, exhibits great disparity in outcome globally[1,2]
Active involvement of the study team members in the development of the interventional bundle could result in changes being made prior to implementation of the interventional bundle. This could result in a lack of significant difference pre- and post-intervention
Only 1–4 patients with gastroschisis will be expected to present during this time in order to utilise the new management bundle whilst the principal investigator (PI) and team are present
Summary
The problem Gastroschisis, one of the commonest congenital anomalies, exhibits great disparity in outcome globally[1,2]. Over the last half century, mortality in HICs has fallen from over 90% in the 1960s to less than 4% today, with the majority of survivors proceeding to live a full, normal life[3,4,5] Such improvements have not been realised in low- and middle-income countries (LMICs) where the majority of births, and cases, occur. Gastroschisis is associated with less than 4% mortality in high-income countries and over 90% mortality in many tertiary paediatric surgery centres across sub-Saharan Africa (SSA). The aim of this trial is to develop, implement and prospectively evaluate an interventional bundle to reduce mortality from gastroschisis in seven tertiary paediatric surgery centres across SSA. Pre- and post-intervention data will be collected on clinical, service delivery and implementation outcomes for 2-years at each site
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