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Updated: Feb 23, 2026

Neurodevelopmental Reflex Testing in Neonatal Rat Pups
Published on: April 24, 2017
Nonpublication and discontinuation of randomised controlled trials in newborns
Christoph M Rüegger1,2, Jennifer A Dawson1,3,4, Susan M Donath3,4
1Newborn Research Centre and Neonatal Services, The Royal Women's Hospital, Parkville, VIC, Australia.
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of 8.0 (range 4.6-17.4) years from Research Ethics Committee approval, 15 of 41 completed trials (37%) remained unpublished, representing 5422 neonatal trial participants.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 reason for discontinuation was poor recruitment (n = 4). Sample size discrepancies between registration and publication were found in 17 (65%) of the 26 completed, published trials. In nine (35%) of these trials, the calculated sample size in the method section of the published article differed from the planned sample size in the trial registry (relative difference -20% to +33%).
Conclusion:
Nonpublication and discontinuation of RCTs conducted in newborns is common. Additional efforts are needed to minimise the number of neonatal trial participants that are exposed to interventions without subsequent publication.
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