Chewable Tablets Produced by Three-Dimensional Printing: A Sensory Acceptability Study in Children and Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Palatability Assessment of 3D-printed Chewable Tablets in Children and Adolescents. Basic parameters: 3 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Sensory acceptability score (5-point facial hedonic scale) [Time frame: Immediately after tablet administration (single assessment per stage)]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
Identifiers
NCT: NCT07424495 · ACEITA3D