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

Poole Hospital NHS Foundation Trust

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT04293107

GRANDCHILD v2.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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).

Trial design

26 participants in 2 patient groups

Phase 1: Content Validity Testing

Description:

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

Description:

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.