Team-based feeding program for young children with neurodevelopmental disorders
Feeding Disorders in Pediatric Age: Effects of an Interdisciplinary Intervention
The program will test whether an interdisciplinary outpatient feeding intervention helps children aged 2–7 with neurodevelopmental disorders who have feeding difficulties.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 2 Years to 7 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT07431671 on ClinicalTrials.gov |
What this trial studies
Children meeting DSM-5 criteria for a neurodevelopmental disorder and with a feeding disorder receive either a structured interdisciplinary intervention or the standard rehabilitation program at an outpatient clinic in Rome. Caregivers complete standardized feeding assessments and questionnaires, and clinicians monitor mealtime behavior, intake, and growth outcomes over the intervention period. The approach integrates medical, nutritional, and behavioral therapies delivered by a coordinated team. The trial aims to implement standardized feeding-related outcome measures into routine outpatient care for this population.
Who should consider this trial
Good fit: Ideal candidates are children aged 2–7 with a DSM-5 neurodevelopmental disorder and a feeding disorder who can feed orally and have caregivers proficient in Italian and not currently enrolled in another feeding program.
Not a fit: Children with medical conditions that prevent oral feeding, caregivers unable to complete Italian-language questionnaires, or those already receiving a different feeding intervention are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the intervention could improve mealtime behaviors, nutritional intake, growth, and family well-being for affected children.
How similar studies have performed: Related multidisciplinary feeding approaches have shown promise, but high-quality outpatient evidence is limited and Italy-specific data are lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 2 and 7 years. * Diagnosis of a neurodevelopmental disorder according to DSM-5 criteria. * Presence of a feeding disorder. Exclusion Criteria: * Presence of respiratory, cardiovascular, gastrointestinal, or neurological conditions preventing oral feeding. * Insufficient caregiver proficiency in the Italian language, such as to compromise completion of the questionnaires. * Children who are undergoing a different feeding intervention at the time of screening.
Where this trial is running
Roma, RM
- IRCCS San Raffaele — Roma, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Elena Cavalieri, SLP
- Email: elena.cavalieri@unicatt.it
- Phone: +39 0652253440
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.