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Feeding Disorders in Children

Feeding Disorders in Children

Recruiting
2-7 years
All
Phase N/A

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Overview

Pediatric Feeding Disorders (PFDs) are conditions characterized by persistent difficulties in food intake, commonly manifesting as food selectivity, food refusal, and dysfunctional mealtime behaviors. Their prevalence in the general pediatric population ranges from 3% to 10%, with substantially higher rates reported among children with neurodevelopmental disorders. The impact of PFDs extends beyond growth and nutritional status, affecting cognitive and emotional development as well as the well-being of the entire family system. Although several treatment models have been proposed, scientific evidence supporting outpatient interventions remains limited and Italy-specific studies are lacking. Moreover, despite the availability of standardized assessment tools, feeding-related outcomes are not yet systematically addressed within outpatient clinical practice for children with neurodevelopmental disorders.

The present study aims to evaluate whether an interdisciplinary intervention protocol involving a psychologist, a speech and language therapist (SLP), and a Neuro and Psychomotor Therapist of Developmental Age (TNPEE) can improve food variety and reduce dysfunctional mealtime behaviors in this population. The study is designed as a pilot randomized controlled trial developed across five sequential phases: participant enrollment and screening using the Montreal Children's Hospital Feeding Scale (MCH-FS); baseline standardized assessment (T0) using the Pediatric Eating Assessment Tool (PediEAT) and the Short Sensory Profile (SSP); random allocation of participants to an experimental group or a control group; delivery of the interdisciplinary intervention exclusively to the experimental group; and a final standardized assessment conducted six weeks later (T1) to evaluate changes over time and between groups.

This pilot study primarily aims to assess feasibility and to estimate the variability of outcome measures; therefore, no formal sample size or power calculation was performed. The planned enrollment of 12 participants per group was determined based on feasibility considerations and in line with CONSORT recommendations for pilot trials. The proposed protocol seeks to address current gaps in the literature by systematically targeting feeding-related outcomes through an explicitly interdisciplinary approach that integrates psychological, speech and language, and neuropsychomotor perspectives in the management of PFD.

Eligibility

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.

Study details
    Neurodevelopmental Disorder (Diagnosis)
    Feeding Disorder
    ARFID

NCT07431671

IRCCS San Raffaele Roma

14 May 2026

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