Long-term outcomes in children born with abdominal wall defects V1
| ISRCTN | ISRCTN14286726 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14286726 |
| Secondary identifying numbers | 17762 |
- Submission date
- 25/02/2015
- Registration date
- 25/02/2015
- Last edited
- 04/08/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Public
University of Oxford
National Perinatal Epidemiology Unit
Old Road
Headington
Oxford
OX3 7LF
United Kingdom
Scientific
University of Oxford
National Perinatal Epidemiology Unit
Old Road
Headington
Oxford
OX3 7LF
United Kingdom
 ORCID ID |
0000-0002-1984-4575 |
|---|
Study information
| Study design | Non-randomised; Interventional and Observational; Design type: Treatment, Cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | AIMES: assessing the long-term impact of early surgical care in children born with abdominal wall defects |
| Study objectives | 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(s) | NRES Committee London - Camberwell St Giles, 23/12/2014, ref: 14/LO/1949 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 20/04/2015 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | 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. |
| Key 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. |
| Key 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. |
| Date of first enrolment | 20/04/2015 |
| Date of final enrolment | 31/08/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Old Road
Headington
Oxford
OX3 7LF
United Kingdom
Sponsor information
Hospital/treatment centre
Wellcome Trust Centre for Human Genetics
Roosevelt Drive
Oxford
OX3 7BN
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
04/08/2017: The overall trial end date has been updated from 31/08/2016 to 31/21/2017.
