Background: The ethical basis of randomised controlled trials is equipoise, whether at the collective or individual level. Neonatal intensive care trials are therefore conducted in a context of clinical uncertainty as well as stress and trauma. The theoretical literature suggests that tensions exist in the trials situation between the aims of care and research. Objectives: To improve understanding of decisions that clinicians and parents make about neonatal trial collaboration, participation and non-participation. Methods: Semi-structured interviews were conducted with 30 neonatologists and 63 parents from 5 UK hospitals who were offered enrolment in the INNOVO and/or CANDA trials. Qualitative analysis was aided by ATLAS-ti. Results: The neonatologists' interviews suggested an intermediate level of equipoise. A therapeutic orientation operated for the INNOVO Trial but not for the CANDA Trial. Neonatologists often did not connect trial participation and trial-related postmortem pathology studies. Most parents made very rapid decisions about trial participation. Perception of risk was independent of the trial under consideration but associated with a slower decision-making process. The 'therapeutic misconception' was present for parents in both trials. Many supported contributing to research. For some of the bereaved parents, this extended to contribution to trial-related pathology studies. Parents who declined the CANDA Trial saw risks in the trial situation. Conclusions: Decisions were complex and multi-tiered. The boundaries between care and research were often unclear for neonatologists and parents. Clarification of the nature of decisions at the heart of clinical trials is needed, so that those associated with research might be willing collaborators and participants, fully cognisant of the activity in which they are engage