Condition category
Not Applicable
Date applied
01/04/2019
Date assigned
17/04/2019
Last edited
17/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 2022

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

Who is the main contact?
Dr Jo Taylor (study manager)
+44 (0)1904 328083
jo.taylor@york.ac.uk

Trial website

https://www.york.ac.uk/healthsciences/research/public-health/projects/different-diets-gastrostomy/

Contact information

Type

Scientific

Primary contact

Dr Johanna Taylor

ORCID ID

Contact details

Health Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321679
jo.taylor@york.ac.uk

Type

Scientific

Additional contact

Dr Lorna Fraser

ORCID ID

Contact details

Health Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321889
lorna.fraser@york.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

41067; HTA 17/76/06

Study information

Scientific title

The role of different diets in children who are gastrostomy fed; an exploratory sequential mixed methods study

Acronym

Study hypothesis

What are the risks, benefits and resource implications for using home-blended food for children with gastrostomy tubes compared to currently recommended formula feeds?

Objectives:
1. To identify the important outcomes of gastrostomy feeding for parents, young people and health professionals
2. To assess the safety of home-blended diets for children who are gastrostomy fed compared to liquid formula diets
3. To identify and quantify the benefits of home-blended diets compared to liquid formula diets for children who are gastrostomy fed and their parents
4. To identify and quantify the resources (family and statutory services) required to support home-blended diets compared to liquid formula diets
5. To assess whether long-term follow-up of children who are gastrostomy fed is feasible using routine data sources

Ethics approval

Approved 20/03/2019, Yorkshire & The Humber - Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ; Tel: +44 (0)207 104 8086; Email: nrescommittee.yorkandhumber-leedswest@nhs.net), ref: 19/YH/0028

Study design

Exploratory sequential mixed methods design

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Children who are gastrostomy fed

Intervention

Stage 1: Interviews of parents (n=20) of children who are gastrostomy fed, young people (n=5-10) who are gastrostomy fed, and relevant healthcare professionals (n=24-32) including paediatrician, dietitians and community nurses. The researchers will ask participants to identify important outcomes for children with a gastrostomy (e.g. symptoms, quality of life, safety, complications) and also explore the best way to measure these outcomes in this study.

Stage 2: 300 children who are gastrostomy fed and their parents will be recruited from children’s health services and followed up for 18 months during which time the outcomes identified from stage 1 will be measured. Detailed clinical information (e.g. diagnosis, medications) will also be collected from the child’s paediatrician and dietitian. The safety and risk of complications will be examined by asking parents about visits to A and E and hospital and also by examining hospital records. At the end of the study the researchers will compare the different outcomes, symptoms, complications, and costs between children who are formula fed and those who are mainly fed blended food.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Gastrointestinal symptoms measured using the PedsQL Gastrointestinal Symptoms module at baseline, 9 and 18 months

Secondary outcome measures

1. Child health-related quality of life measured using the PedsQL Generic module at baseline, 9 and 18 months
2. Parent health-related quality of life measured using the EQ5D-5L at baseline, 9 and 18 months
3. Dietary intake measured using parent-reported food diaries and using the MyFood24 dietary assessment tool at baseline, 9 and 18 months
4. Anthropometric measurements (weight, height/length, body mass index, mid upper arm circumference, multiple skin folds) measured at baseline, 9 and 18 months
5. Healthcare usage (appointments with paediatric and dietetic teams, emergency hospital admissions, GP attendance, A&E visits) measured at baseline, 9 and 18 months
6. Safety (parent-reported tube blockages, A&E or hospital visits to unblock or replace the gastrostomy device, gut or stoma site infections and antibiotics prescribed for these) measured at baseline, 9 and 18 months
7. Resource use (cost of feeds, including dietetic resources, cost of equipment to prepare feeds, time to prepare and administer feeds) measured at baseline, 9 and 18 months

Outcomes are subject to change based on the results of phase 1 of the study

Overall trial start date

01/02/2019

Overall trial end date

31/07/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Workstream 1:
1. Parents of children and young people (aged 6 months up to 18 years) who are fed via a gastrostomy
2. Young people aged 12-18 years currently using a gastrostomy and with no significant cognitive impairments
3. Health professionals, specifically paediatricians, dietitians, children’s community nurses, and Speech and Language Therapists

Workstream 2:
Children (aged 6 months - 18 years inclusive) who receive all or part of their nutrition via gastrostomy tube, and their parent/guardian

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

Workstream 1: 20 parents, 5-10 young people, 24-32 health professionals; Workstream 2: 300 children and their parents (n=600 participants)

Participant exclusion criteria

1. Children with a temporary gastrostomy
2. Infants up to 6 months and young people who are 19 years and older
3. Non-residents of England

Recruitment start date

01/03/2019

Recruitment end date

31/07/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

City Hospitals Sunderland NHS Foundation Trust
Sunderland Royal Hospital Kayll Road
Sunderland Tyne and Wear
SR4 7TP
United Kingdom

Trial participating centre

Poole Hospital NHS Foundation Trust
Longfleet Road
Poole
BH15 2JB
United Kingdom

Trial participating centre

Manchester University NHS Foundation Trust
Cobbett House Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

York Teaching Hospital NHS Foundation Trust
York Hospital Wigginton Road
York
YO31 8HE
United Kingdom

Trial participating centre

Birmingham Women's and Children's NHS Foundation Trust
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom

Trial participating centre

South Staffordshire and Shropshire Healthcare NHS Foundation Trust
Trust Headquarters St. Georges Hospital Corporation Street
Stafford
ST16 3SR
United Kingdom

Trial participating centre

Cambridgeshire Community Services NHS Trust
Unit 3 Meadow Lane
St. Ives
PE27 4LG
United Kingdom

Trial participating centre

Birmingham Community Healthcare NHS Foundation Trust
3, Priestley Wharf Holt Street Birmingham Science Park Aston
Birmingham
B7 4BN
United Kingdom

Trial participating centre

Heart of England NHS Foundation Trust
Birmingham Heartlands Hospital Bordesley Green East
Birmingham
B9 5ST
United Kingdom

Trial participating centre

Walsall Healthcare NHS Trust
Manor Hospital Moat Road
Walsall
WS2 9PS
United Kingdom

Trial participating centre

Shrewsbury and Telford Hospital NHS Trust
Mytton Oak Road
Shrewsbury
SY3 8XQ
United Kingdom

Trial participating centre

Wye Valley NHS Trust
County Hospital Union Walk
Hereford
HR1 2ER
United Kingdom

Trial participating centre

The Dudley Group NHS Foundation Trust
C Block Russells Hall Hospital Pensnett Road
Dudley
DY1 2HQ
United Kingdom

Trial participating centre

Worcestershire Health and Care NHS Trust
Isaac Maddox House Shrub Hill Industrial Estate
Worcester
WR4 9RW
United Kingdom

Trial participating centre

Leeds Community Healthcare NHS Trust
Stockdale House 8 Victoria Road
Leeds
LS6 1PF
United Kingdom

Trial participating centre

Somerset Partnership NHS Foundation Trust
2nd Floor Mallard Court Express Park Bristol Road
Bridgwater
TA6 4RN
United Kingdom

Trial participating centre

Solent NHS Trust
Solent NHS Trust Headquarters Highpoint Venue Bursledon Road
Southampton
SO19 8BR
United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Trust Headquarters Queens Medical Centre Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital Freeman Road High Heaton
Newcastle Upon Tyne
NE7 7DN
United Kingdom

Trial participating centre

Guy's and St Thomas' NHS Foundation Trust
Trust Offices Guy's Hospital Great Maze Pond
London
SE1 9RT
United Kingdom

Trial participating centre

Alder Hey Children's NHS Foundation Trust
Alder Hey Hospital Eaton Road West Derby
Liverpool
L12 2AP
United Kingdom

Trial participating centre

Childrens Hospice South West
Charlton Farm
Bristol
BS48 1PE
United Kingdom

Trial participating centre

University of York
Department of Health Sciences
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York

Sponsor details

Heslington Hall
York
YO10 5DD
United Kingdom
+44 (0)1904328693
michael.barber@york.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Peer reviewed scientific journals
2. Conference presentation
3. Publication on website
4. NIHR funder report

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to being unable to share the linked healthcare data which is important in the analyses.

Intention to publish date

31/07/2023

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/04/2019: Uploaded protocol Version 1.1, 5 March 2019 (not peer reviewed). 15/04/2019: Trial's existence confirmed by the NIHR.