Nonpublication and discontinuation of randomised controlled trials in newborns

Abstract

Aim: To determine the rate of nonpublication and discontinuation of randomised controlled trials (RCTs) in newborns. Methods: This was a retrospective, cross-sectional study of RCTs registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR) between 2008 and 2012. Results: Fifty trials were identified, of which 23 (46%) were retrospectively registered. Thirty trials (60%) were published. After a median follow-up of 8.0 (range 4.6–17.4) years from Research Ethics Committee approval, 15 of 41 completed trials (37%) remained unpublished, representing 5422 neonatal trial participants. Nine trials (18%) were discontinued, including four that were published. The most frequent ..