Reporting on data monitoring committees in neonatal randomised controlled trials is inconsistent

Aim To evaluate the reported use of data monitoring committees ( DMC s), the frequency of interim analysis, prespecified stopping rules and early trial termination in neonatal randomised controlled trials ( RCT s). Methods We reviewed neonatal RCT s published in four high‐impact general medical journals, specifically looking at safety issues including documented involvement of a DMC , stated interim analysis, stopping rules and early trial termination. We searched all journal issues over an 11‐year period (2003–2013) and recorded predefined parameters on each item for RCT s meeting inclusion criteria. Results Seventy neonatal trials were identified in four general medical journals: Lancet, New England Journal of Medicine ( NEJM ), British Medical Journal and Journal of American Medical Association. A total of 43 (61.4%) studies reported the presence of a DMC , 36 (51.4%) explicitly mentioned interim analysis, stopping rules were reported in 15 (21.4%) RCT s and seven (10%) trials were terminated early. The NEJM most frequently reported these parameters compared to the other three journals reviewed. Conclusion While the majority of neonatal RCT s report on DMC involvement and interim analysis, there is still scope for improvement. Clear documentation of safety‐related issues should be a central component of reporting in neonatal trials involving newborn infants.