Developing, Piloting and Evaluating a Therapeutic Programme for Neonates Using the Plan-Do-Study-Act Framework

Introduction. Complicated births are often associated with functional disorders in neonates. Some literature suggests alternative therapies (e.g. Craniosacral Therapy (CST) and parental education) as an appropriate substitute for stronger interventions in such cases. This pilot study aimed to develop, implement and evaluate a therapeutic programme for neonates with functional disorders based on CST and parental education in a university hospital setting. Methods. The Plan-Do-Study-Act framework was used. The programme, named ‘Wellcome’, was developed using an interprofessional approach. Pain, agitation symptoms and breastfeeding problems were the functional disorders targeted. A pilot phase was implemented to investigate: i) programme usage, ii) experience of it and attitudes towards it, iii) its operationalisation, and iv) its clinical effects. Quantitative and qualitative data were collected. A stakeholder dialogue completed the evaluation phase, and a roadmap was developed for future implementation steps. Results. The pilot phase included 25 neonates, selected mostly for breastfeeding problems (72%). The attitudes towards Wellcome were generally positive. However, several aspects of its operationalisation (e.g. inclusion criteria) should be revised based on a combination of literature research, interprofessional exchange, and possibly primary research. The pilot study showed that the clinical effects were generally positive, although vaguely described. Discussion. The goal described in the roadmap was to proceed with piloting and collect further data. In parallel, conflicting points regarding inclusion criteria, human resources, and scientific evidence must be addressed in a structured manner. The structure envisages an iterative process that allows rapid progression without losing the momentum gained during this first pilot phase.