NCT03724214

Multi-Centre Gastroschisis Interventional Study Across Sub-Saharan Africa

Developing and Implementing an Interventional Bundle to Reduce Mortality From Gastroschisis in Low-Resource Settings

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 235 (estimated)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is a multi-centre interventional study at seven tertiary paediatric surgery centres in Ghana, Zambia, Malawi and Tanzania aimed at reducing mortality from gastroschisis.

Detailed description

Background: Gastroschisis has a great disparity in outcomes globally with less than 4% mortality in high-income countries (HICs) and over 90% mortality in many tertiary paediatric surgery centres across sub-Saharan Africa (SSA), including the study centres. Low-technology, cost-effective, evidence-based interventions are available with the potential for improved outcomes in low-resource settings. Aim: To develop, implement and prospectively evaluate an interventional care bundle to reduce mortality from gastroschisis in seven tertiary paediatric surgery centres across SSA. Study Design: A hybrid type 2 effectiveness-implementation study design will be utilised, which focusses equally on the effectiveness of the intervention through analysing clinical outcomes and effectiveness of the implementation through analysis of service delivery and implementation outcomes. Methods: Using current literature an evidence-based, low-technology interventional care bundle has been developed with both pre-hospital and in-hospital components. During 2018 a systematic review, qualitative study and Delphi process will provide further evidence in order to optimise the interventional bundle and implementation strategy for use in low-resource environments. The interventional care bundle has core components, which will remain consistent across the seven sites, and adaptable components, which will be determined through in-country co-development meetings with all relevant members of the multi-disciplinary team. Across the seven study sites it is estimated that 180-289 patients will be included in the study, which has the potential to determine a difference in pre- and post-intervention mortality between 10-15%. Implementation will take place over a 4-week period at each of the study sites between April - December 2019. Pre- and post-interventional data will be collected on clinical, service delivery and implementation outcomes between September 2018 to October 2020 (2-years of patient recruitment at each site with a 30-day post primary intervention follow-up period). 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 management protocols. Implementation outcomes will include acceptability, adoption, appropriateness, feasibility, fidelity, coverage, cost and sustainability. Expected Results: Pre- and post-intervention clinical outcomes will be compared using Chi-squared analysis, unpaired t-test and/ or Mann-Whitney test. 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 both clinical and implementation factors affecting outcome with adjustment for confounders. P\<0.05 will be deemed significant. Outcome: This will be the first multi-centre interventional study to the investigator's 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.

Conditions

• Gastroschisis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Pre-hospital interventional care bundle	The interventional care bundle will include pre-hospital and in-hospital components and core and adaptable components. All seven centres will implement the core pre-hospital and in-hospital components. Implementation of the adaptable components will be decided by the local team to optimise the interventional care bundle to the local environment. Pre-hospital core components: 1) covering the bowel in clear plastic, 2) administering intravenous fluids, 3) keeping the neonate warm, 4) transferring to a study centre as soon as possible. This will be implemented as a pre-hospital gastroschisis care protocol to district and secondary level hospitals who refer patients with gastroschisis to the study centres. Pre-hospital adaptable components: 1) the strategy for disseminating the pre-hospital gastroschisis care protocol.
COMBINATION_PRODUCT	In-hospital interventional care bundle	In-hospital core components: 1) use of a standardised care protocol, 2) neonatal resuscitation and ward care including intravenous access, intravenous fluids, maintenance of normothermia, appropriate antibiotics, regular monitoring and infection control, 3) gastroschisis reduction and sutureless closure using a preformed silo and avoidance of neonatal anaesthesia and surgery, 4) early establishment of breastfeeding and an enhanced enteral feeding programme. In-hospital adaptable components: 1) administration of parenteral nutrition for neonates who have survived for 1-week in hospital, 2) maternal involvement in monitoring and basic management, 3) management of neonates with gastroschisis on the neonatal intensive care unit if available.

Timeline

• Start date: 2018-10-08
• Primary completion: 2020-11-08
• Completion: 2021-01-31
• First posted: 2018-10-30
• Last updated: 2020-02-26

Locations

9 sites across 6 countries: Canada, Ghana, Malawi, Tanzania, United Kingdom, Zambia