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NCT07895914
Validation of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
Conditions: Pediatric Feeding Disorder, Feeding Difficulties in Infants and Young Children
Sex: All
Ages: 8 Months – 18 Months
Healthy volunteers: No
Enrollment: 100
Sponsor: University Hospital, Strasbourg, France
Location: Pediatric Surgery Department, Hautepierre Hospital, University Hospital of Strasbourg, France Strasbourg
Summary
This single-center observational study aims to evaluate the validity of the D-TAP parental questionnaire for early screening of pediatric feeding disorder (PFD) in hospitalized children aged 8 to 18 months. Currently, no standardized screening test is routinely used by all healthcare professionals in France to identify PFD, despite its reported prevalence and potential consequences for child development, family well-being, and healthcare costs.
The D-TAP questionnaire will be compared with the Montreal Children's Hospital Feeding Scale. A blinded clinical speech-language pathology assessment of information collected during a semi-structured parental interview will be used to identify signs suggestive of PFD.
A total of 100 children will be included. The study will assess the diagnostic performance of the D-TAP questionnaire, identify an optimal screening threshold, and explore whether parents initiate contact with a community-based speech-language therapist within six weeks after being informed of signs suggestive of PFD.
Eligibility Criteria
Inclusion Criteria:
* Children aged 8 to 18 months, inclusive, receiving care within the pediatric medical-surgical department at the Hautepierre site.
* Children born at or after 37 weeks of gestation. Parents who are French-speaking.
* Parents affiliated with a social security or health insurance scheme.
* Parents who have agreed to participate in the study.
Exclusion Criteria:
* Parents who refuse participation.
* Children diagnosed with a neurodevelopmental disorder.
* Children with oromyofacial malformations.
* Children with digestive conditions affecting oral feeding, including esophageal achalasia, esophageal atresia, necrotizing enterocolitis, gastroschisis, Hirschsprung disease, eosinophilic esophagitis, omphalocele, chronic intestinal pseudo-obstruction, or short bowel syndrome.
* Children with neurological conditions affecting feeding, including pediatric stroke, spinal muscular atrophy, developmental and epileptic encephalopathies, congenital myopathies, cerebral palsy, CHARGE syndrome, congenital myasthenic syndromes, Prader-Willi syndrome, Rett syndrome, Smith-Lemli-Opitz syndrome, traumatic brain injury, or trisomy.
* Children with a history of prolonged hospitalization or invasive care during the neonatal period.
* Children currently receiving or previously having received artificial nutrition, whether enteral or parenteral.
Source: ClinicalTrials.gov (NCT07895914). StuddyBuddy aggregates publicly available trial information.