Multi-Centre Gastroschisis Interventional Study Across Sub-Saharan Africa
NCT ID: NCT03724214
Last Updated: 2020-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
235 participants
INTERVENTIONAL
2018-10-08
2021-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pre-intervention
Patients presenting with simple gastroschisis during the pre-intervention phase will receive the current care provided by the study sites (no intervention).
No interventions assigned to this group
Post-intervention
Patients presenting with simple gastroschisis during the post-implementation phase will receive the interventional care bundle if consent for participation is provided.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Korle-Bu Teaching Hospital, Accra, Ghana
OTHER
Komfo Anokye Teaching Hospital
OTHER
Ministry of Health, Ghana
OTHER_GOV
University Teaching Hospital, Lusaka, Zambia
OTHER
Arthur Davison Children's Hospital
OTHER
Kamuzu Central Hospital
OTHER
Muhimbili National Hospital, Dar es Salaam, Tanzania.
UNKNOWN
King's College London
OTHER
Responsible Party
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Principal Investigators
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Naomi J Wright, MBChB BSc MRCS DCH MSc
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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McGill University
Montreal, , Canada
Korle-Bu Teaching Hospital
Accra, , Ghana
Komfo Anokye Teaching Hospital
Kumasi, , Ghana
Tamale Teaching Hospital
Tamale, , Ghana
Kamuzu Central Hospital
Lilongwe, , Malawi
Muhimbili National Hospital
Dar es Salaam, , Tanzania
King's Centre for Global Health and Health Partnerships, King's College London
London, , United Kingdom
University Teaching Hospital
Lusaka, , Zambia
Arthur Davison Children's Hospital
Ndola, , Zambia
Countries
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Central Contacts
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Facility Contacts
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References
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Wright N, Abantanga F, Amoah M, Appeadu-Mensah W, Bokhary Z, Bvulani B, Davies J, Miti S, Nandi B, Nimako B, Poenaru D, Tabiri S, Yifieyeh A, Ade-Ajayi N, Sevdalis N, Leather A. Developing and implementing an interventional bundle to reduce mortality from gastroschisis in low-resource settings. Wellcome Open Res. 2019 Mar 8;4:46. doi: 10.12688/wellcomeopenres.15113.1. eCollection 2019.
Other Identifiers
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GISSA2017-20
Identifier Type: -
Identifier Source: org_study_id
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