ARE CANADIAN NEONATOLOGISTS READY FOR A STEM CELL TRIAL FOR BRONCHOPULMONARY DYSPLASIA?

Abstract

Abstract BACKGROUND Pre-clinical studies support the role of stem cells in preventing bronchopulmonary dysplasia (BPD), a chronic lung disease of prematurity. We are planning the first Canadian clinical trial of stem cell therapy for BPD. OBJECTIVES To ensure successful bench-to-bedside translation, the objective of our study was to identify the barriers and enablers that may influence neonatologists’ decision to identify extremely preterm infants at risk of BPD for participation in a stem cell trial for BPD. DESIGN/METHODS Semi-structured interviews were conducted with neonatologists across Canada. We used the Theoretical Domains Framework (TDF) to develop an interview topic guide covering 14 key domains that influence behavior (e.g. knowledge, intentions, goals, social influences). Two independent researchers used directed content analysis (using qualitative software NVIVO 11) to assign utterances to TDF thematic domains. We further identified sub-themes within domains to identify key barriers and enablers to neonatologists identifying infants for the planned trial. RESULTS Sixteen interviews were conducted with neonatologists across Canada (Western Canada n=7, Central Canada n=7, Eastern Canada n=2). Seven were practicing as a neonatologist for 10 years or less, 5 for 11–20 years and 4 for >20 years. Preliminary analyses demonstrated that neonatologists are eager to help identify patients for this study due to the importance they place on trying to treat BPD. Many participants had worries concerning the lack of evidence on long-term outcomes of stem cell therapy. Access to clear protocols, well defined eligibility criteria, and research assistants were brought up as key facilitators for screening patients. The most commonly reported barrier included the need for human resources (e.g. research assistants), funding, and institutional support to help screen patients. CONCLUSION Our interviews identified facilitators and barriers from a neonatologist perspective to a potential stem cells trial for BPD. Our findings will inform the design of a phase I/II clinical trial.