Multi-Centre Gastroschisis Interventional Study Across Sub-Saharan Africa

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

Interventions

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.

Sponsors & Collaborators

• Korle-Bu Teaching Hospital, Accra, Ghana

  collaborator OTHER

• Komfo Anokye Teaching Hospital

  collaborator OTHER

• Ministry of Health, Ghana

  collaborator OTHER_GOV

• University Teaching Hospital, Lusaka, Zambia

  collaborator OTHER

• Arthur Davison Children's Hospital

  collaborator OTHER

• Kamuzu Central Hospital

  collaborator OTHER

• Muhimbili National Hospital, Dar es Salaam, Tanzania.

  collaborator UNKNOWN

• King's College London

  lead OTHER

Principal Investigators

• Naomi J Wright, MBChB BSc MRCS DCH MSc · King's College London

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-08

Primary Completion

2020-11-08

Completion

2021-01-31

Countries

• Canada
• Ghana
• Malawi
• Tanzania
• United Kingdom
• Zambia

Study Locations