Cerebral PalsyGRANDCHILDNCT04293107
Gastro-oesophageal Reflux and NeuroDisability (Cerebral Palsy) in CHILDren
An observational study of Cerebral Palsy and GORD, run by Poole Hospital NHS Foundation Trust at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Cerebral Palsy, GORD, Pediatrics
- How many people
- 26 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 22 Jan 2021to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Parents/carers of children (2-16 years) with cerebral palsy and GORD.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Poole Hospital NHSFT
Poole, Dorset, BH15 2JB
Lee Tbaily, 0300 019 2025, lee.tbaily@uhd.nhs.uk
- Recruiting
Poole Hospital
Poole, Dorset, BH15 2JB
Nash, 44 1202 448798
Mark Tighe
About this study
Official title: Using the Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ) in Children With Cerebral Palsy: a Preliminary Validation Study
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.
Read the detailed 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.
- Conditions
- Cerebral Palsy, GORD, Pediatrics, GERD in Children, Quality of Life
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
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).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start22 Jan 2021
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poole Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- British Society of Paediatric Gastroenterology, Hepatology and Nutrition
- Responsible party
- Sponsor
- Investigators
- Mark P Tighe, MRCPCH, Principal investigator, University Hospitals Dorset NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293107
- Sponsor's protocol ID
- GRANDCHILD v2.0
- Acronym
- GRANDCHILD
- Status last verified
- Nov 2023
- First submitted
- 27 Feb 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21464757
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ) in Children With Cerebral Palsy: a Preliminary Validation Study
- ClinicalTrials.gov ID
- NCT04293107
- Acronym / sponsor ID
- GRANDCHILD / GRANDCHILD v2.0
- Conditions
- Cerebral Palsy, GORD, Pediatrics, GERD in Children, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Poole Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- British Society of Paediatric Gastroenterology, Hepatology and Nutrition
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Parents/carers of children (2-16 years) with cerebral palsy and GORD.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phase 1: Valid modified Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ)
Time frame: 1 day
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 secondary outcome
Phase 2: Reliability of modified Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 21464757Kleinman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark P Tighe, MRCPCH principal investigator
University Hospitals Dorset NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and GORD, run by Poole Hospital NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lee Tbaily (+44 (0)1202 442025, researchsponsorship@uhd.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Valid modified Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293107, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.