The role of different diets in children who are gastrostomy fed

Plain English summary of protocol

Background and study aims
There are growing numbers of children living in England who require to be fed through a tube directly into the stomach (gastrostomy). The current professional recommendations in England are that formula feeds should be used when children are fed by gastrostomy, but there are growing numbers of parents who are choosing to feed their own children a more conventional diet of home-blended foods. This study aims to address a research gap by assessing the symptom profile (reflux, constipation, pain) and quality of life of children who are gastrostomy fed, comparing those who are formula fed and those who are predominantly fed a home-blended diet. The study will also examine the impact on parents’ quality of life and explore costs to the families and the NHS.

Who can participate?
Children aged between 6 months and 18 years old (inclusive) who have a gastrostomy for nutritional purposes

What does the study involve?
There are two phases in this study.
Phase 1 involves interviews with parents and young people, and group discussions with health professionals, to explore the different diets that children receive and the resources (e.g. time, cost) associated with gastrostomy feeding. The study also identifies which outcomes (e.g. quality of life, complications with feeding, healthcare use) are the most important to measure for children with a gastrostomy, and how to measure these. The findings are used to decide what information should be collected from children and their families in phase 2.
Phase 2 is a study of children who are gastrostomy fed, some of who receive the recommended formula feeds and some of who receive a diet of home-blended foods. Information is collected from this group of children and their parents at the beginning of the study, and then again at 9 and 18 months, to compare the outcomes for children who receive formula feeds with those who receive home-blended feeds.

What are the possible benefits and risks of participating?
There are no direct benefits associated with taking part in this study. However, this study will provide important evidence about the risks and benefits associated with these different diets, which will be used to improve the advice and support that is available to families, and also healthcare staff who support them. There is no risk to children who take part in this study because they are not asked to change their diet or the way they are fed, or to keep things the same if their feeding needs to change. It is possible that some parents who take part in the study experience distress as a result of talking about their child’s gastrostomy, and the study team will ensure appropriate support is available.

Where is the study run from?
The study is being run by Dr Lorna Fraser and a team of researchers based in the Department of Health Sciences at the University of York. Families will be recruited from NHS services throughout England who provide nutritional care for children and young people with a gastrostomy.

When is the study starting and how long is it expected to run for?
February 2019 to July 2023

Who is funding the study?
National Institute of Health Research (NIHR) Health Technology Assessment (HTA) programme (UK)

Who is the main contact?
Dr Julia Hackett, julia.hackett@york.ac.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

University of York
University/education

Heslington Hall
York
YO10 5DD
England
United Kingdom

Phone	+44 (0)1904328693
Email	michael.barber@york.ac.uk
"ROR"	https://ror.org/04m01e293

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

ISRCTN13977361_PROTOCOL_v1.1_05Mar19.pdf

Uploaded 17/04/2019

ISRCTN13977361_PROTOCOL_v1.3_21Apr20.pdf

Uploaded 02/02/2021

ISRCTN13977361_PROTOCOL_20Apr21.pdf

Uploaded 21/05/2021

ISRCTN13977361_PROTOCOL_V1.4_20Apr21.pdf

ISRCTN13977361_PlainEnglishResults.pdf

Editorial Notes

15/01/2024: Publication reference and plain English results added.
27/12/2023: Publication reference added.
21/09/2023: The following changes were made to the trial record:
1. The IRAS number was added.
2. The intention to publish date was changed from 30/09/2023 to 31/12/2023.
01/08/2023: The following changes have been made:
1. The intention to publish date has been changed from 31/07/2023 to 30/09/2023.
2. The final enrolment number has been changed from 242 to 567.
02/03/2023: The following changes were made to the trial record:
1. Protocol uploaded (not peer reviewed).
2. Contact details updated.
3. Total final enrolment added.
18/10/2021: A scientific contact was added.
21/05/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2021 to 31/10/2021.
2. The overall trial end date has been changed from 31/07/2022 to 31/07/2023.
3. Publication reference added.
4. The total final enrolment number has been added from the reference.
5. Uploaded protocol version 1.4, 20 April 2021 (not peer reviewed).
17/02/2021: The recruitment end date has been changed from 28/02/2021 to 30/06/2021.
02/02/2021: The following changes have been made:
1. Uploaded protocol version 1.3, 21 April 2020 (not peer reviewed).
2. The trial participating centres "York Teaching Hospital NHS Foundation Trust", "Walsall Healthcare NHS Trust", and "Alder Hey Children's NHS Foundation Trust" have been removed.
3. The trial participating centre has been changed from "South Staffordshire and Shropshire Healthcare NHS Foundation Trust" to "Shropshire Community Health NHS Trust".
4. The trial participating centres "Harrogate and District NHS Foundation Trust", "Sussex Community NHS Foundation Trust", "Royal Wolverhampton NHS Trust", "Northern Lincolnshire and Goole NHS Foundation Trust", "Airedale NHS Foundation Trust ", "Bradford Teaching Hospitals NHS Foundation Trust", "Lincolnshire Community Health Services NHS Trust", and "Hull University Teaching Hospitals NHS Trust" have been added.
07/08/2020: The recruitment end date has been changed from 31/07/2020 to 28/02/2021.
01/07/2020: The recruitment has resumed.
17/04/2020: Due to current public health guidance, recruitment for this study has been paused.
10/10/2019: Publication reference added, trial website address updated.
17/04/2019: Uploaded protocol Version 1.1, 5 March 2019 (not peer reviewed).
15/04/2019: Trial's existence confirmed by the NIHR.