Multi-Centre Gastroschisis Interventional Study Across Sub-Saharan Africa

NCT03724214 | Unknown DMC

• 1 other identifier: GISSA2017-20
• Study Type: interventional
• Target: 235
• Locations: 6 countries
• Sites: 9

Brief 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.

Conditions

Gastroschisis

Keywords

Gastroschisis; Sub-Saharan Africa; Low-resource settings; Low- and middle-income countries; Mortality; Outcomes; Implementation science; Intervention

Outcome Measures

Primary Outcomes (1)

• All-cause, in-hospital mortality

  Percentage of patients with gastroschisis dying in hospital during their primary admission.

  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*

  Within 30-days of primary intervention.

• Length of hospital stay amongst survivors

  Up to a maximum of 30-days following primary intervention.

• Time to full enteral feeds

  Up to a maximum of 30-days following primary intervention.

• Need for ventilation

  Up to a maximum of 30-days following primary intervention.

• Duration of ventilation

  Up to a maximum of 30-days following primary intervention.

Other Outcomes (21)

• Service delivery outcomes: time from birth to arrival at the study centre

  Time from birth to arrival at the study centre (typically less than 1 week)

• Service delivery outcomes: proportion of patients with clear plastic bowel coverage prior to arrival to the study centre

  Birth to arrival at the study centre (typically less than 1 week)

• Service delivery outcomes: proportion of patients with intravenous fluids prior to arrival at hospital.

  Birth to arrival at the study centre (typically less than 1 week)

Study Arms (2)

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.

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

Interventions

Pre-hospital interventional care bundle COMBINATION_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.

Post-intervention

In-hospital interventional care bundle COMBINATION_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.

Post-intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King's College London: lead
• Korle-Bu Teaching Hospital, Accra, Ghana: collaborator
• Komfo Anokye Teaching Hospital: collaborator
• Ministry of Health, Ghana: collaborator
• University Teaching Hospital, Lusaka, Zambia: collaborator
• Arthur Davison Children's Hospital: collaborator
• Kamuzu Central Hospital: collaborator
• Muhimbili National Hospital, Dar es Salaam, Tanzania.: collaborator

Study Sites (9)

McGill University

Montreal, Canada

NOT YET RECRUITING

Korle-Bu Teaching Hospital

Accra, Ghana

RECRUITING

Komfo Anokye Teaching Hospital

Kumasi, Ghana

NOT YET RECRUITING

Tamale Teaching Hospital

Tamale, Ghana

RECRUITING

Kamuzu Central Hospital

Lilongwe, Malawi

NOT YET RECRUITING

Muhimbili National Hospital

Dar es Salaam, Tanzania

NOT YET RECRUITING

King's Centre for Global Health and Health Partnerships, King's College London

London, SE5 9RJ, United Kingdom

NOT YET RECRUITING

University Teaching Hospital

Lusaka, Zambia

NOT YET RECRUITING

Arthur Davison Children's Hospital

Ndola, Zambia

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 30984879 DERIVED

MeSH Terms

Conditions

Gastroschisis

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Naomi J Wright, MBChB BSc MRCS DCH MSc

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi J Wright, MBChB BSc MRCS DCH MSc

CONTACT

0044 7824468954; paedsurg.research@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: October 30, 2018
• Study Start: October 8, 2018
• Primary Completion: November 8, 2020
• Study Completion: January 31, 2021
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

MA (1); ZA (2); TA (1); CA (1); GB (1); GH (3)