跳至主要内容
临床试验/NCT07431671
NCT07431671招募中不适用

Feeding Disorders in Pediatric Age: Effects of an Interdisciplinary Intervention

IRCCS San Raffaele Roma1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
24
试验地点
1
主要终点
Pediatric Eating Assessment Tool (PediEAT) Total Score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 2 and 7 years.
  • Diagnosis of a neurodevelopmental disorder according to DSM-5 criteria.
  • Presence of a feeding disorder.

排除标准

  • 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.

研究组 & 干预措施

Experimental Group

Experimental

干预措施: Interdisciplinary intervention (Other)

Control Group

Active Comparator

干预措施: Standard rehabilitation program (Other)

结局指标

主要结局

Pediatric Eating Assessment Tool (PediEAT) Total Score

时间窗: Baseline and immediately post-intervention (6 weeks)

The Pediatric Eating Assessment Tool (PediEAT) is a standardized parent-report questionnaire consisting of 78 items assessing observable feeding-related symptoms in children aged 6 months to 7 years. Items are rated on a 6-point Likert scale, and a total score is calculated, with higher scores indicating greater feeding-related concern.

次要结局

未报告次要终点

研究者

发起方
IRCCS San Raffaele Roma
申办方类型
Other
责任方
Sponsor

研究点 (1)

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