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
Prof 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 measure
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
31/12/2017
Reason abandoned (if study stopped)
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
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
unknown
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list