Multi-Centre Gastroschisis Interventional Study Across Sub-Saharan Africa

King's College London

Status: Unknown

Conditions: Gastroschisis

Treatments: Combination Product: In-hospital interventional care bundle; Combination Product: Pre-hospital interventional care bundle

Study type: Interventional

Funder types: Other

Identifiers

NCT03724214

GISSA2017-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 235 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• all neonates presenting primarily to the study centre with simple gastroschisis regardless of weight, gestational age or co-morbidities.

Exclusion criteria

• all neonates with 'complex gastroschisis' requiring surgical intervention for bowel necrosis, perforation, atresia or other reason.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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235 participants in 2 patient groups

Pre-intervention

No Intervention group

Description:

Patients presenting with simple gastroschisis during the pre-intervention phase will receive the current care provided by the study sites (no intervention).

Post-intervention

Active Comparator group

Description:

Patients presenting with simple gastroschisis during the post-implementation phase will receive the interventional care bundle if consent for participation is provided.

Treatment:

Combination Product: Pre-hospital interventional care bundle

Combination Product: In-hospital interventional care bundle