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Набор скоро начнётся NCT07424495

Chewable Tablets Produced by Three-Dimensional Printing: A Sensory Acceptability Study in Children and Adolescents

— Наблюдательное Palatability Assessment of 3D-printed Chewable Tablets in Children and Adolescents

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Palatability Assessment of 3D-printed Chewable Tablets in Children and Adolescents. Базовые параметры: 3 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The lack of appropriate pediatric formulations compromises adherence and the effectiveness of oral treatment in children, mainly due to the splitting of adult tablets and low sensory acceptability. This observational, analytical, and cross-sectional study aims to evaluate the acceptability of a novel pediatric dosage form consisting of placebo chewable tablets produced by 3D printing, with a focus on palatability and feasibility for dose personalization. Children and adolescents aged 3 to 18 years receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar will be invited to participate. The study will be conducted in two stages. In the first stage, acceptability of a bear-shaped chewable tablet will be assessed, as well as preference among different flavors. In the second stage, preference for chewable tablets with or without xylitol will be investigated, in addition to dysgeusia associated with diseases or chronic medication use. Acceptability will be measured using a 5-point facial hedonic scale, evaluator observation, and age-appropriate questionnaires. The study is expected to identify the most accepted flavors and sweetness intensities, as well as to evaluate the acceptability of the 3D-printed dosage form, contributing to the development of safer, more attractive, and personalized pediatric medicines.

Первичные конечные точки

  • Sensory acceptability score (5-point facial hedonic scale) [Срок оценки: Immediately after tablet administration (single assessment per stage)]

Критерии участия

Критерии включения

  • Children and adolescents aged 3 to 18 years receiving care at the Nutrition Outpatient Clinic of the Hospital da Criança de Brasília José Alencar (HCB).
  • Written informed consent provided by the legal guardian through the signing of the Informed Consent Form (ICF).
  • Assent from the child or adolescent, when applicable, expressed through the signing of the Informed Assent Form (IAF).

Критерии исключения

  • Children or adolescents with dietary restrictions or known allergies to any component present in the formulations used in the study.
  • Children or adolescents with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Children or adolescents diagnosed with severe neurological, cognitive, or behavioral disorders that impair communication, comprehension, or response to the sensory scale.
  • Oral conditions, mucosal lesions, or dysphagia that prevent or significantly impair proper chewing or swallowing of the tablet (e.g., mucositis).
  • Refusal of the child/adolescent or legal guardian to participate in the study at any time, even after prior consent has been provided.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Lajoinie A, Janiaud P, Henin E, Gleize J-C, Berlion C, Nguyen KA, Nony P, Gueyffier F, Maucort-Boulch D, Kassaï Koupaï B. Assessing the effects of solid versus liquid dosage forms of oral medications on adherence and acceptability in children. Cochrane Database of Systematic Reviews 2017, Issue 9. Art. No.: CD012783. DOI: 10.1002/14651858.CD012783.
  • Abdel-Rahman SM, Bai S, Porter-Gill PA, Goode GA, Kearns GL. A Pilot Comparison of High- Versus Low-Tech Palatability Assessment Tools in Young Children. Paediatr Drugs. 2021 Jan;23(1):95-104. doi: 10.1007/s40272-020-00430-2. Epub 2020 Nov 25. PMID 33236188
  • Mistry P, Stirling H, Callens C, Hodson J, Batchelor H; SPaeDD-UK project. Evaluation of patient-reported outcome measurements as a reliable tool to measure acceptability of the taste of paediatric medicines in an inpatient paediatric population. BMJ Open. 2018 Jul 11;8(7):e021961. doi: 10.1136/bmjopen-2018-021961. PMID 29997143
  • van Riet-Nales DA, de Neef BJ, Schobben AF, Ferreira JA, Egberts TC, Rademaker CM. Acceptability of different oral formulations in infants and preschool children. Arch Dis Child. 2013 Sep;98(9):725-31. doi: 10.1136/archdischild-2012-303303. Epub 2013 Jul 13. PMID 23853004

Идентификаторы

NCT: NCT07424495 · ACEITA3D

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗