Condition category
Surgery
Date applied
25/02/2015
Date assigned
25/02/2015
Last edited
18/03/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Gastroschisis and exomphalos are birth defects in which the wall of the abdomen fails to close properly. Although we have good information about these babies when they are born, there is very little research which investigates the health of babies born with these conditions over the longer-term, i.e. as they are children growing up. In particular, we don’t know how the severity of their condition when they are born, and how the different types of surgery used to close the abdominal wall affect children’s long-term health and quality of life. This research project into children born with abdominal wall defects aims to find out ways to improve treatment and provide better information about the conditions for families by finding out about their health when they are 7-9 years old.

Who can participate?
Surviving children with gastroschisis born in the UK between October 2006 and March 2008. Children with exomphalos born in the UK between March 2014 and February 2015 who survives to one month of age or is discharged from hospital.

What does the study involve?
Parents of children with gastroschisis aged 7-9 are sent two questionnaires, one for them and one for their child to fill in. These contain questions about their child’s health and wellbeing. There are questions about symptoms they may or may not be having and about whether they have been to the doctors or to hospital recently. There are also some general questions about how they feel in themselves, questions about how their tummy looks and how they and their parents feel about it. There are also questions on the impact that having a child with gastroschisis has had on the family.
Parents are also asked whether we can contact their child’s teacher to ask some questions about how their child gets on at school. If parents do not wish their child’s teacher to be contacted, the information they provide through returning the questionnaires is still included in the study.
Parents of children with exomphalos born between March 2014 and September 2015 are contacted and asked to provide their contact details in order to take part in future questionnaire studies when their children are older.

What are the possible benefits and risks of participating?
The study will not be of direct benefit to participating parents or their children, as the information will be used to improve treatment in the future. It will not change the treatment they currently receive. The questions in the questionnaires are very general and many have been used in other studies involving children, but some parents may find some of them sensitive or upsetting. It is absolutely fine to only answer some, but not all of the questions. Parents will have the direct contact details of the research team and if they are upset or distressed by anything they are asked they will be able to talk to someone from the research team.

Where is the study run from?
29 NHS hospitals in the UK

When is the study starting and how long is it expected to run for?
April 2015 to August 2016

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mrs Melanie O’Connor

Trial website

Contact information

Type

Public

Primary contact

Mrs Melanie O'Connor

ORCID ID

Contact details

University of Oxford
National Perinatal Epidemiology Unit
Old Road
Headington
Oxford
OX3 7LF
United Kingdom

Type

Scientific

Additional contact

Professor Marian Knight

ORCID ID

http://orcid.org/0000-0002-1984-4575

Contact details

University of Oxford
National Perinatal Epidemiology Unit
Old Road
Headington
Oxford
OX3 7LF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17762

Study information

Scientific title

AIMES: assessing the long-term impact of early surgical care in children born with abdominal wall defects

Acronym

Study hypothesis

This project will investigate children born with abdominal wall defects assessing both school and patient/ parent-reported outcomes. Teachers, parents and children will be asked to complete a questionnaire about their/the child's general health and well-being. The data generated from this study will relate outcomes to severity of disease and initial operative management in order to inform evidence-based practice and parental counselling.

Ethics approval

NRES Committee London - Camberwell St Giles, 23/12/2014, ref: 14/LO/1949

Study design

Non-randomised; Interventional and Observational; Design type: Treatment, Cohort study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Topic: Children; Subtopic: All Diagnoses; Disease: All Diseases

Intervention

The interventions to be investigated all relate to the initial surgical management after birth. The four main groups to be examined will be:
Infants with simple gastroschisis managed initially with operative fascial closure
Infants with simple gastroschisis managed initially with a preformed silo
Infants with simple gastroschisis managed initially with any other closure method
Infants with complex gastroschisis managed initially with any closure method.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Health-related quality of life; Timepoint(s): 7 - 9 years of age

Secondary outcome measures

Morbidity; Timepoint(s): 7 - 9 years of age

Overall trial start date

20/04/2015

Overall trial end date

31/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Any surviving infant with gastroschisis born in the UK between October 2006 and March 2008 who completes, or their parent completes, a questionnaire.
2. Any infant with exomphalos born in the UK between March 2014 and February 2015 who survives to one month of age or discharge home whose parent provides their contact details.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 500; UK Sample Size: 500; Description: All recruitment to take place at the University of Oxford with 28 Participant Identification Centres across the UK.

Participant exclusion criteria

1. Any infant with gastroschisis born in the UK between October 2006 and March 2008 who has subsequently died.
2. Any infant with exomphalos born in the UK between March 2014 and February 2015 who dies before one month of ageor discharge home.

Recruitment start date

20/04/2015

Recruitment end date

31/08/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
National Perinatal Epidemiology Unit Old Road Headington
Oxford
OX3 7LF
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Wellcome Trust Centre for Human Genetics
Roosevelt Drive
Oxford
OX3 7BN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The findings of this study will be presented at specialist conferences, such as the BAPS Annual Congress in July 2017. Resulting work will also be submitted for publication in peer-reviewed journals, with an anticipated publication date of Autumn 2017. Findings will also be fed back to a parental advisory group and thence, to the relevant patient and parent groups.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes