Abstract
BACKGROUND: Preterm birth is a significant contributor to neonatal morbidity and mortality. Despite legislative efforts to increase pediatric drug development, neonatal clinical trials continue to be infrequent. The International Neonatal Consortium (INC) includes nurses as key stakeholders in their mission to accelerate safe and effective therapies for neonates. PURPOSE: INC developed a survey for nurses, physicians, and parents to explore communication practices and stakeholders' perceptions and knowledge regarding clinical trials in neonatal intensive care units (NICUs). METHODS: A stepwise consensus approach was used to solicit responses to an online survey. The convenience sample was drawn from INC organizations representing the stakeholder groups. Representatives from the National Association of Neonatal Nurses and the Council of International Neonatal Nurses, Inc, participated in all stages of the survey development process, results analysis, and publication of results. RESULTS: Participants included 188 nurses or nurse practitioners, mainly from the United States, Canada, the European Union, and Japan; 68% indicated some level of research involvement. Nurses expressed a lack of effective education to prepare them for participation in research. Results indicated a lack of a central information source for staff and systematic approaches to inform families of studies. The majority of nurses indicated they were not asked to provide input into clinical trials. Nurses were uncertain about research consent and result disclosure processes. IMPLICATIONS FOR PRACTICE AND RESEARCH: This study indicates the need to educate nurses in research, improve NICU research communication through standardized, systematic pathways, and leverage nurse involvement to enhance research communication.