Gastro-oesophageal Reflux and NeuroDisability (Cerebral Palsy) in CHILDren

Quality of Life Clinical Trial

— GRANDCHILD  

Official title:

Using the Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ) in Children With Cerebral Palsy: a Preliminary Validation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04293107
• Other study ID #: GRANDCHILD v2.0
• Status: Recruiting
• Start date: January 22, 2021
• Est. completion date: March 2024

Study information

• Verified date: November 2023
• Source: Poole Hospital NHS Foundation Trust
• Contact: Lee Tbaily
• Phone: +44 (0)1202 442025
• Email: researchsponsorship[@]uhd.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study assesses the content validity of the PGSQ for parents/carer of children with cerebral palsy and GORD, including features such as readability, face validity and acceptability for completion. This will be done via 6 interviews, with the PGSQ being altered as identified as required. Reliability (test-retest) of the adapted version of the PGSQ being assessed with a sample of 20 parents/carers.

Description:

Gastro-oesophageal reflux disease (GORD) is a common condition, where acid from the stomach leaks up into the oesophagus (food pipe) causing highly unpleasant symptoms and sometimes needing hospital admission. Children with cerebral palsy suffer from a poorly contracting food pipe (oesophageal dysmotility). As a result, GORD is more problematic in these children and more common; of the 8000 children with cerebral palsy aged 5-16 in the UK, around half suffer from reflux disease. This is treated with medicines or surgery. There is not an accurate measure of their symptoms, though there is a suitable questionnaire in well children (the PGSQ). National Institute for Health and Clinical Excellence (NICE) have recommended research to assess the effectiveness of medicines to treat GORD in these children (NG1 research recommendation). In the first phase, the investigators will ask 6 parents/carers their opinions about the PGSQ using qualitative interviews, and alter the PGSQ if needed; then in the second phase, ask 20 parents/carers about their child's symptoms to understand the reliability of the PGSQ at two time points 2 weeks apart (test-retest). The investigators won't do any invasive tests on the children but will ask parents about their opinions of their children taking part in pH-impedance monitoring, which is used to assess severity of GORD and may be useful in designing future studies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

• Parents or carers of children with cerebral palsy (GMFCS level III-V) with symptoms of GORD or on treatment for presumed GORD, aged between 2-16 years.

Exclusion Criteria:

• Children whose parent/carer are not able to support their participation in the study in the opinion of the investigator (e.g. language/communication issue, health, burden).

Related Conditions & MeSH terms

• Cerebral Palsy
• GERD in Children
• GORD
• Pediatrics
• Quality of Life

Locations

Country	Name	City	State
United Kingdom	Poole Hospital	Poole	Dorset
United Kingdom	Poole Hospital NHSFT	Poole	Dorset

Sponsors (2)

Lead Sponsor	Collaborator
Poole Hospital NHS Foundation Trust	British Society of Paediatric Gastroenterology, Hepatology and Nutrition

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Kleinman L, Nelson S, Kothari-Talwar S, Roberts L, Orenstein SR, Mody RR, Hassall E, Gold B, Revicki DA, Dabbous O. Development and psychometric evaluation of 2 age-stratified versions of the Pediatric GERD Symptom and Quality of Life Questionnaire. J Pediatr Gastroenterol Nutr. 2011 May;52(5):514-22. doi: 10.1097/MPG.0b013e318205970e. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Valid modified Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ)	Qualitative feedback on whether the Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ) needs modification or is useful and appropriate for patents/carers of children with cerebral palsy and GORD.	1 day
Secondary	Phase 2: Reliability of modified Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ)	The difference in scores in the modified PGSQ performed twice, 2 weeks apart, compared with visual analogue symptom (VAS) scores to demonstrate test-retest reliability. VAS scores run from a scale of 0 (no symptoms) to 10 (severe symptoms).	2 weeks