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

NCT04293107 | Unknown

• 1 other identifier: GRANDCHILD v2.0
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Phase 2: Reliability of modified Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ)

  2 weeks

Study Arms (2)

Phase 1: Content Validity Testing

Cohort of 6 parents/carers of children with cerebral palsy and GORD, who will be interviewed regarding the content validity of the PGSQ when used to assess symptoms of GORD in children with cerebral palsy.

Phase 2: Reliability (test-retest) Testing

Cohort of 20 parents/carers of children with cerebral palsy and GORD, who will review and complete the adapted version of the PGSQ (post Phase 1) at two time points, two weeks apart.

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Parents/carers of children (2-16 years) with cerebral palsy and GORD.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Poole Hospital NHS Foundation Trust: lead
• British Society of Paediatric Gastroenterology, Hepatology and Nutrition: collaborator

Study Sites (2)

Poole Hospital NHSFT

Poole, Dorset, BH15 2JB, United Kingdom

RECRUITING

Poole Hospital

Poole, Dorset, BH15 2JB, United Kingdom

RECRUITING

Related 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.

  PMID: 21464757 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mark P Tighe, MRCPCH

  University Hospitals Dorset NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Tbaily

CONTACT

+44 (0)1202 442025; researchsponsorship@uhd.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 3, 2020
• Study Start: January 22, 2021
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)