Adapting and validating a swallowing assessment tool for children
Adaptation and Validation of the Logopaedic Assessment Protocol Mealtime Assessment Scale (MAS) in Paediatric Patients
This study is testing a new swallowing assessment tool for children to see if it can help understand how well they eat and swallow during meals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 24 Months to 18 Years |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 1 site (Florence) |
| Trial ID | NCT06094595 on ClinicalTrials.gov |
What this trial studies
This study aims to adapt the Mealtime Assessment Scale (MAS) for use in a pediatric population to evaluate swallowing efficacy and safety during meals. It involves a three-phase process, beginning with the adaptation of the original MAS scale, which was validated for adults, by a multidisciplinary team of specialists. The scale includes various subscales that assess factors influencing eating and swallowing, with a scoring system to quantify impairment levels. The study will be conducted in an ecological setting, allowing for real-world observations of mealtime administration.
Who should consider this trial
Good fit: Ideal candidates are children aged 24 months to 18 years with risk factors for swallowing disorders who can tolerate oral feeding.
Not a fit: Patients who rely exclusively on alternative feeding methods, such as nasogastric tubes or PEG, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a validated tool for assessing swallowing disorders in children, leading to improved management and care.
How similar studies have performed: Other studies have successfully validated similar assessment tools for adult populations, but this adaptation for children is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 24 months and 18 years * Presence of risk factors for swallowing disorders of different etiology and severity at clinical evaluation * Tolerance to exclusive oral feeding of a full or partial meal Exclusion Criteria: * Exclusive use of alternative feeding methods: nasogastric tube, percutaneous endoscopic gastrostomy (PEG), percutaneous endoscopic gastro-jejunal (PEG J) * Absent or non-compliant caregiver
Where this trial is running
Florence
- IRCCS Fondazione Don Carlo Gnocchi Onlus — Florence, Italy (Recruiting)
Study contacts
- Principal investigator: Giovanna Cristella, MD — IRCCS Fondazione Don Carlo Gnocchi ONLUS
- Study coordinator: Giovanna Cristella, MD
- Email: gcristella@dongnocchi.it
- Phone: 0557393949
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.