Title: STAMP (Study into Thin orodispersible film Acceptability as Medicine for Preschool children)
Funder: Department of Health (England)

Abstract: Background In recent years increased attention and funding has rightly been focussed on the development of new drugs to treat children's diseases. Much less research has been carrried out into formulations which allow both new and established drugs to be administered to young children, and as a result the formulations available for most paediatric drugs (tablets/capsules or liquids) have changed little in decades. Both parents and professionals are aware of the problems involved in administering these formulations to preschool children in particular, and these problems may be exaggerated when children are acutely unwell and at their least cooperative. Problems of administration may lead in the short term to inadequate or inaccurate dosage, and in the long term to poor compliance. A wider range of formulations is now becoming available, but available advice on their suitability for different ages and conditions (eg from the European Medicines Agency - EMA) is based on opinion and consensus rather than evidence. Research to investigate the suitability of newer dosage forms is urgently required. Orodispersible films (ODFs) are thin, postage-stamp sized strips which dissolve easily in the mouth, and appear particularly promising in the preschool age group, but there are as yet no empirical data on their suitability for preschool children. The aim of this study is to examine the acceptability and ease of use of ODFs in young children between 6 months and 5 years 11 months of age. The primary objective is to describe accurately the acceptability of ODFs across this age range. Secondary objectives are to examine how acceptability varies with age and with clinical situation (stable versus acute illness). The important question we wish to answer is: are ODFs an appropriate formulation for preschool children; if so, how young can they be given; and can they still be used in acutely unwell children? Plan of investigation We will address this question by administering placebo ODFs to children in hospital between 6 months and 5 years 11 months of age, in two settings: stable children attending the outpatient department (OPD) and acutely unwell children attending the Children's Emergency Department (CED). Acceptability and ease of use will be measured by questionnaires including rating scales administered to parents, and by picturial rating scales administered directly to children 3 years old and over. Sampling will be stratified to ensure an even distribution of children across the age range. Data on acceptability will be presented descriptively, and also compared between age groups and between OPD vs CED settings. Potential benefits If we demonstrate that ODFs are an acceptable formulation for preschool children, we can then work with pharmaceutical companies to explore using these formulations to deliver essential drug treatments. This could lead to more child-friendly treatments, more effective therapy, and better compliance with treatment.


Research activity codes: 6.1 PHARMACEUTICALS
Health categories: GENERIC HEALTH RELEVANCE