Acceptability of minitablets in soft food. A randomised cross-over study in children

Objective: To evaluate the acceptability of placebo minitablets mixed with different volumes of soft food in children aged 6 months to 7 years. Methods: In this UK hospital-based, randomised cross-over study, children received placebo minitablets in yoghurt or apple sauce. Those under 1 year received one sample; older children received two. All participants were video recorded taking the samples. Minitablet counts (50-135), and soft food volumes (7.5-30 mL) increased with age. Children aged 1 year + were randomised to "high" or "low" soft food volumes for the first sample; parents chose the soft-food amount for younger children. Swallowability was rated (1-5) by researchers, and palatability by independent reviewers ('pleasant', 'neutral', or 'unpleasant'). Palatability and swallowability scores were then combined to assess overall acceptability using the composite endpoint tool. Children aged 4-7 years completed a participant questionnaire. Results: 100 children were grouped by age: