Jos M. Latour

Background There is limited literature regarding family and staff experiences of participating in clinical trials. A qualitative study was embedded in the NAVABronch feasibility trial evaluating the effectiveness of a novel mode of ventilation, neurally adjusted ventilatory assist (NAVA), in infants with acute viral bronchiolitis. Aims and Objectives The aim of this qualitative study was to explore the experiences of parents and health care practitioners (HCPs) involved in the NAVABronch Trial. Study Design Semi‐structured interviews were conducted with two parents and two focus groups were held with six HCPs. Findings Four themes were identified from the focus groups: (1) Creating staff engagement, (2) Education to deliver NAVA, (3) Normalizing NAVA in clinical practice (4) Creating meaningful study outcomes and (5) support of parents during the trial, this theme was generated from the parent interviews. The findings indicated the need for education regarding NAVA for HCPs which would lead to increased confidence, better guidance around the use of NAVA and the need for NAVA to be normalized and embedded into the unit culture. Parents identified the need for further support around preparation for what may happen as a result of the interventions, particularly the weaning of sedation. Conclusion Our study indicates that staff and parents had no concerns regarding the trial methods and procedures. Relevance to Clinical Practice Conducting clinical trials in Paediatric Intensive Care Units (PICUs) is challenging and complex. There is limited literature regarding family and staff experiences of participating in clinical trials. Understanding their experiences is crucial in ensuring trial success.