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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-22

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical and Instrumental Evaluation of Swallowing in Children With Cerebral Palsy

NCT01031771

Cerebral Palsy Deglutition Disorders

COMPLETED

Ultrasound Assessed Gastric Volume in the Fasted Pediatric Cerebral Palsy Patients

NCT05185336

Cerebral Palsy

UNKNOWN

Management of Drooling in Children With Cerebral Palsy in France

NCT02797106

Cerebral Palsy Pathological Drooling

COMPLETED

Functional Endoscopic Evaluation of Swallowing

NCT00717028

Cerebral Palsy Dysphagia

COMPLETED

Gastric Volume in the Fasted Pediatric Cerebral Palsy Patients

NCT04918277

Aspiration, Respiratory Cerebral Palsy

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy GORD Pediatrics GERD in Children Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No