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Proportion of Infant Neurodevelopment Trials Reporting a Null Finding: A Systematic Review
Megan Finch-Edmondson1,2, Madison C B Paton1,2, Ingrid Honan1,2
1Cerebral Palsy Alliance Research Institute, Specialty of Child and Adolescent Health, Sydney Medical School.
Pediatrics
|January 25, 2023
Summary
Over 70% of infant neurodevelopment trials report null findings, suggesting potential issues in study design and methodology. Future research requires more sophisticated approaches to improve intervention efficacy assessment.
Area of Science:
- Neuroscience and Developmental Psychology
- Clinical Trial Methodology
- Pediatric Health Interventions
Background:
- Improving neurodevelopmental outcomes in infants is critical, but clinical trials face challenges.
- Methodological limitations in infant neurodevelopment trials can impact the interpretation of intervention efficacy.
Approach:
- Systematic review of randomized controlled trials (RCTs) for infant-directed interventions.
- Searched multiple databases (Cochrane, Medline, Embase, CINAHL) for studies.
- Included RCTs recruiting infants <6 months with neurodevelopment as a primary outcome.
Key Points:
- Over 70% of the 18 superiority trials reviewed reported null findings.
- Factors contributing to null results include outcome selection, timing, effect size, sample size, and statistical rigor.
- Publication bias may underestimate the true proportion of null findings.
Conclusions:
- Infant neurodevelopment trials exhibit a high rate of null findings.
- Methodological and design considerations significantly influence trial outcomes.
- Recommendations include advanced trial design, outcome assessment, and statistical analysis for future studies.
