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The role of different diets in children who are gastrostomy fed

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13977361
Enrollment
662
Registered
2019-04-17
Start date
2019-03-01
Completion date
Unknown
Last updated
2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children who are gastrostomy fed Not Applicable

Interventions

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, dieti

Sponsors

University of York
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026