Clinical Research Directory

Feeding Disorders in Children

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.

Comparison of Sucking in Premature Infants and Infants With Pierre Robin Sequence

The NUTROBIN study aims to analyze sucking in two populations of vulnerable children who require intensive and prolonged care, and whose treatment has an impact on the subsequent development of oral function. This development has a significant impact on the overall psychomotor development. * Prematurity and oral function Very premature birth, before 29 weeks is associated with significant neonatal morbiditywhich interferes with the development of oral competencies. The coordination of sucking, swallowing, and breathing, which is necessary for oral feeding, commonly matures after 34 weeks postconceptional age (Quetin 2015). During the first weeks of life, the oral sphere of these babies is both under-stimulated due to the enteral feeding via a fed via a gastric tube, and negatively stimulated due to fixation of the tube on the perioral area together with regular necessary tube changes. The more premature an infant is, the more significant these disturbances are, delaying the acquisition of feeding autonomy (Lau 2020), which is essential for discharge from the hospital. Positive oral stimulation, such as non-nutritive sucking (pacifier), and perioral stimulation can support the development of oral feeding in these vulnerable infants. Many questions remain regarding the development of sucking in premature infants, as there are few tools available to analyse it accurately. * NUTRIO study in premature infants This is a prospective, single-centre, RIPH 3 non-health product study. It was set up in the Croix Rousse neonatal unit, in collaboration with Prof. Luc Marlier, CNRS Strasbourg, who developed a succiometre. The objective is to measure sucking parameters and describe their evolution in a population of extremely premature infants whose daily care includes an oral stimulation program. Enrolment in the NUTRIO study began in January 2025 and is currently ongoing. Ten infants have been enrolled, and a total of 30 are expected to be included. * The DYSROBIN study in infants with Pierre Robin sequence This is a prospective, multicentre study that aimed to evaluate the involvement of brainstem dysfunction in the pathophysiology of Pierre Robin sequence. To assess brainstem dysfunction, several tests were performed to collect the various elements that make up the spectrum of dysautonomia: central sleep apnoea (nighttime polysomnography), cardiac variability abnormalities (24-hour Holter ECG), gastroesophageal reflux (pH monitoring, impedance measurement), sucking difficulties (sucking measurement). A group of infants with Pierre Robin sequence (upper airway obstruction, suspected brainstem involvement) was compared to a group of infants with isolated airway obstruction (laryngomalacia, choanal atresia, etc.) and healthy infants. Inclusions were completed in 2022 and included 53 infants with Pierre Robin sequence. Two ancillary publications have been produced, one submission is imminent, and the main study is currently being written. Justification for the NUTROBIN study: This study will help to better define the sucking profile of infants with Pierre Robin sequence in order to determine the actions to be taken to support oral function in these infants from the first weeks of life and limit the neurodevelopmental consequences and the impact on the quality of life of the infant and their family caused by oral function disorders. The public interest of the study lies in the fact that it will clarify the specificities of the sucking and swallowing profile of infants with Pierre Robin sequence, enable families to be better informed about these children's oral disorders, and thus offer targeted, personalized multidisciplinary care (paediatrician, speech therapist, dietitian).