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Impact of Parental Education on Positional Plagiocephaly Prevention: A Randomized Controlled Trial
Background: Positional plagiocephaly, characterized by cranial asymmetry, has increased significantly following the implementation of the Back-to-Sleep campaign. While this initiative successfully reduced the incidence of Sudden Infant Death Syndrome, it inadvertently led to a 5-fold increase in plagiocephaly cases. This condition can result in aesthetic concerns, psychosocial issues, and functional challenges, including difficulties with headgear fitting. Despite its prevalence, many parents and caregivers remain unaware of plagiocephaly and its prevention strategies. This study aims to assess the impact of targeted parental education on plagiocephaly prevention and to provide evidence-based recommendations for clinical practice.
Methods: Our prospective, randomized control trial included full-term newborns (≤14 days old) without congenital craniofacial anomalies. Subjects were randomly assigned to intervention (n=75) or control (n=75) groups using a computer-generated randomization sequence. The intervention group received a comprehensive educational package consisting of an informative pamphlet and a 3-minute video on plagiocephaly awareness, risk factors, and prevention strategies. The control group received standard care without additional educational materials.
Cephalic index, calculated from head circumference, biparietal diameter, and anteroposterior diameter, was assessed at enrollment and subsequent 2, 4, and 6-month well-child visits. The primary outcome measure was the difference in cephalic index between groups at the 6-month follow-up.
Results: Our institution's previous pilot study (n=39) demonstrated a statistically significant difference in cephalic index between intervention and control groups. The intervention group showed a smaller average cephalic index, indicating reduced plagiocephaly incidence. The interim findings are limited by gaps in the 2, 4, and 6-month follow-up data. Our goal is to complete data collection for all 150 patients by year-end, which will reinforce the statistical significance of the study and allow for more robust conclusions. Currently, forty new subjects have been enrolled (n=79) and 18 two-month follow-ups have been completed. While preliminary analysis of this additional data is ongoing, it is premature to draw definitive conclusions about its statistical impact on the overall study results.
Conclusion: Our interim findings indicate that targeted parental education may effectively reduce plagiocephaly incidence and improve long-term cranial development outcomes. This study underscores the importance of preventive education in pediatric care and its potential to mitigate an avoidable condition with long-term implications. The educational intervention appears to enhance parental knowledge and promote adherence to preventive measures.