Proportion of Infant Neurodevelopment Trials Reporting a Null Finding: A Systematic Review

Discovering new interventions to improve neurodevelopmental outcomes is a priority; however, clinical trials are challenging and methodological issues may impact the interpretation of intervention efficacy. Characterize the proportion of infant neurodevelopment trials reporting a null finding and identify features that may contribute to a null result. The Cochrane library, Medline, Embase, and CINAHL databases. Randomized controlled trials recruiting infants aged 70% reported a null finding. Features were identified that may have contributed to the high proportion of null findings, including selection and timing of the primary outcome measure, anticipated effect size, sample size and power, and statistical analysis methodology and rigor. Publication bias against null studies means the proportion of null findings is likely underestimated. Studies assessing neurodevelopment as a secondary or within a composite outcome were excluded. This review identified a high proportion of infant neurodevelopmental trials that produced a null finding and detected several methodological and design considerations which may have contributed. We make several recommendations for future trials, including more sophisticated approaches to trial design, outcome assessment, and analysis.