GastroschisisNCT03724214
Multi-Centre Gastroschisis Interventional Study Across Sub-Saharan Africa
A study testing Pre-hospital interventional care bundle and In-hospital interventional care bundle in people with Gastroschisis, run by King's College London at 9 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastroschisis
- What is being tested?
- Pre-hospital interventional care bundle and In-hospital interventional care bundle
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 8 Oct 2018to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all neonates presenting primarily to the study centre with simple gastroschisis regardless of weight, gestational age or co-morbidities.
Who cannot join
- all neonates with 'complex gastroschisis' requiring surgical intervention for bowel necrosis, perforation, atresia or other reason.
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Ghana3 sites, 3 recruiting
- Recruiting
Korle-Bu Teaching Hospital
Accra
William Appeadu-Mensah, wappmens@gmail.com
Afua Hesse, afuahesse@gmail.com
- Not yet recruiting
Komfo Anokye Teaching Hospital
Kumasi
Michael Amoah, daddylumba@hotmail.com
Boateng Nimako, bnimako@yahoo.com
- Recruiting
Tamale Teaching Hospital
Tamale
Stephen Tabiri, kstephenba@yahoo.com
Francis Abantanga, frankabantanga@hotmail.com
Zambia2 sites, 2 recruiting
- Not yet recruiting
University Teaching Hospital
Lusaka
Bruce Bvulani, bvulanib@yahoo.com
Rae Oranmore Brown, raeobrown@icloud.com
- Not yet recruiting
Arthur Davison Children's Hospital
Ndola
Sam Miti, drsammiti@gmail.com
Mwewa Mwape, mwapemwewa2000@yahoo.com
Canada1 site, 1 recruiting
- Not yet recruiting
McGill University
Montreal
Dan Poenaru, dpoenaru@gmail.com
Dan Poenaru
Malawi1 site, 1 recruiting
- Not yet recruiting
Kamuzu Central Hospital
Lilongwe
Bip Nandi, bipnandi@hotmail.com
Omar Jagot, omarmagnum@gmail.com
Tanzania1 site, 1 recruiting
- Not yet recruiting
Muhimbili National Hospital
Dar es Salaam
Zaitun Bokhary, zaitunsanya2005@gmail.com
Godfrey Sama, godfreysama2@yahoo.com
United Kingdom1 site, 1 recruiting
- Not yet recruiting
King's Centre for Global Health and Health Partnerships, King's College London
London, SE5 9RJ
Naomi J Wright, MBChB BSc MRCS DCH MSc, 0044 7824468954, paedsurg.research@gmail.com
Andrew Leather, MS FRCS FRCS(Ed), 0044 20 7848 5806, andy.leather@kcl.ac.uk
About this study
Official title: Developing and Implementing an Interventional Bundle to Reduce Mortality From Gastroschisis in Low-Resource Settings
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.
Read the 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
- Being tested
- Pre-hospital interventional care bundle, In-hospital interventional care bundle
- Keywords
- Gastroschisis, Sub-Saharan Africa, Low-resource settings, Low- and middle-income countries, Mortality, Outcomes, Implementation science, Intervention
- Medical subject headings
- Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-hospital interventional care bundleCombination product
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 bundleCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | No intervention | 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 | Patients presenting with simple gastroschisis during the post-implementation phase will receive the interventional care bundle if consent for participation is provided. Receives: Combination Product: Pre-hospital interventional care bundle; Combination Product: In-hospital interventional care bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause, in-hospital mortality
Percentage of patients with gastroschisis dying in hospital during their primary admission.
Measured: Mortality whilst in hospital during primary admission, up to 30-days post-intervention or 30-days from admission for those not receiving an intervention and still in hospital.
Secondary outcomes (5)
Percentage of patients experiencing a major complication within 30-days of primary intervention*
Major complications are secondary bowel ischaemia, necrosis or perforation requiring resection, abdominal compartment syndrome* or need for further unplanned surgical intervention.
*Defined as the first bowel intervention the neonate received including silo application or primary closure.
**Defined as bowel necrosis or perforation that was not present prior to primary intervention and hence occurred after primary intervention.
***Defined as respiratory insufficiency secondary to compromised tidal volumes, decreased urine output by falling renal perfusion (<1ml/kg/hr) and any other organ dysfunction caused by increased intra-abdominal pressure (based on clinical judgement - the pressure does not have to be measured to fulfil the criteria).
Measured: Within 30-days of primary intervention.
Length of hospital stay amongst survivors
In days.
Measured: Up to a maximum of 30-days following primary intervention.
Time to full enteral feeds
In days
Measured: Up to a maximum of 30-days following primary intervention.
Need for ventilation
Yes/ no. This does not include ventilation given during anaesthesia for intervention(s).
Measured: Up to a maximum of 30-days following primary intervention.
Duration of ventilation
IN days. All ventilation types included.
Measured: Up to a maximum of 30-days following primary intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start8 Oct 2018
- Primary completion8 Nov 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroschisisStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Pre and post study design. All patients presenting with simple gastroschisis during the pre-intervention phase will receive the current care provided by the study site. All patients with simple gastroschisis presenting to a study site following implementation will receive the interventional care bundle (if consent is provided).
- Masking
- None (open label)
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Korle-Bu Teaching Hospital, Accra, Ghana, Komfo Anokye Teaching Hospital, Ministry of Health, Ghana, University Teaching Hospital, Lusaka, Zambia, Arthur Davison Children's Hospital, Kamuzu Central Hospital, Muhimbili National Hospital, Dar es Salaam, Tanzania.
- Responsible party
- Sponsor
- Investigators
- Naomi J Wright, MBChB BSc MRCS DCH MSc, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724214
- Sponsor's protocol ID
- GISSA2017-20
- Status last verified
- Feb 2020
- First submitted
- 12 Sep 2018
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following publication, the full anonymised dataset will be made opening available to the public.
Publications
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.
PubMed 30984879
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Implementing an Interventional Bundle to Reduce Mortality From Gastroschisis in Low-Resource Settings
- ClinicalTrials.gov ID
- NCT03724214
- Acronym / sponsor ID
- GISSA2017-20
- Conditions
- Gastroschisis
- Keywords
- Gastroschisis, Sub-Saharan Africa, Low-resource settings, Low- and middle-income countries, Mortality, Outcomes, Implementation science, Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Korle-Bu Teaching Hospital, Accra, Ghana, Komfo Anokye Teaching Hospital, Ministry of Health, Ghana, University Teaching Hospital, Lusaka, Zambia, Arthur Davison Children's Hospital, Kamuzu Central Hospital, Muhimbili National Hospital, Dar es Salaam, Tanzania.
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 8 Nov 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre and post study design. All patients presenting with simple gastroschisis during the pre-intervention phase will receive the current care provided by the study site. All patients with simple gastroschisis presenting to a study site following implementation will receive the interventional care bundle (if consent is provided).
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | No intervention | –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 | Combination Product: Pre-hospital interventional care bundle, Combination Product: In-hospital interventional care bundlePatients presenting with simple gastroschisis during the post-implementation phase will receive the interventional care bundle if consent for participation is provided. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all neonates presenting primarily to the study centre with simple gastroschisis regardless of weight, gestational age or co-morbidities.
Key exclusion criteria (1 listed)
- all neonates with 'complex gastroschisis' requiring surgical intervention for bowel necrosis, perforation, atresia or other reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-hospital interventional care bundleThe 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 | Post-intervention |
| In-hospital interventional care bundleIn-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. | Combination product | Post-intervention |
Primary outcome
All-cause, in-hospital mortality
Time frame: Mortality whilst in hospital during primary admission, up to 30-days post-intervention or 30-days from admission for those not receiving an intervention and still in hospital.
Percentage of patients with gastroschisis dying in hospital during their primary admission.
5 secondary outcomes
Percentage of patients experiencing a major complication within 30-days of primary intervention*
Time frame: Within 30-days of primary intervention.
Length of hospital stay amongst survivors
Time frame: Up to a maximum of 30-days following primary intervention.
Time to full enteral feeds
Time frame: Up to a maximum of 30-days following primary intervention.
Need for ventilation
Time frame: Up to a maximum of 30-days following primary intervention.
Duration of ventilation
Time frame: Up to a maximum of 30-days following primary intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Derived from this study: PubMed 30984879Wright 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.
- Individual participant dataSharing planned: Yes. Following publication, the full anonymised dataset will be made opening available to the public.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi J Wright, MBChB BSc MRCS DCH MSc principal investigator
King's College London
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-hospital interventional care bundle and In-hospital interventional care bundle in people with Gastroschisis, run by King's College London at 9 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Ghana, Zambia, Canada, Malawi, Tanzania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naomi J Wright, MBChB BSc MRCS DCH MSc (0044 7824468954, paedsurg.research@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause, in-hospital mortality (time frame: Mortality whilst in hospital during primary admission, up to 30-days post-intervention or 30-days from admission for those not receiving an intervention and still in hospital.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03724214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.