Velopharyngeal Anatomy and Speech Production in Cleft Palate Surrounding Primary Palatoplasty: Protocol for a Prospective Observational Pilot Study

Background Children with cleft palate often experience impaired speech due to atypical velopharyngeal anatomy following palate repair surgery. While surgical repair aims to restore the function of the palate, more than one-third of cases result in continued velopharyngeal insufficiency (VPI) and require reoperation, which can result in negative psychosocial impacts and financial burden. Common surgical approaches for primary palatoplasty, including intravelar veloplasty and double-opposing Z-plasty, have similar reported rates of VPI. Furthermore, procedure selection occurs without any presurgical imaging and varies by operating surgeon. Surgical decisions are often based on intraoperative judgment rather than objective measures. Structural and functional variables have been associated with speech outcomes in this population, but these data exist independently of one another until the school-age years, failing to establish a direct connection between anatomy and functionality of the velopharynx in toddlers. The current clinical paradigm misses a critical window of opportunity for earlier diagnosis of VPI. Objective The purpose of this study is to (1) establish which presurgical anatomical variables are predictive of surgical procedure selection based on perceptual assessment of intraoperative tension for palate repair and (2) determine which postsurgical anatomical features are associated with the greatest diversity in oral stop consonant production at 18 months in children with a repaired cleft palate. Methods A total of 30 infants with cleft palate will be recruited prior to palate repair. Within 2 weeks of repair, participants will undergo nonsedated magnetic resonance imaging (MRI) of the velopharynx and produce a home-based speech recording. Participants will complete the same protocol after palate repair at 18 months of age. Data will be analyzed by independent raters following completion of a training protocol. Anatomical dimensions of the velopharynx will be extracted from the MRI scans. The number and diversity of oral stop consonants will be extracted from the speech recordings. Interrater and intrarater reliability will be assessed. Logistic regression will be used to evaluate which presurgical anatomical measurements are predictive of surgical procedure selection. Analysis of covariance will be used to examine whether postsurgical anatomical measurements are associated with diversity of oral stop consonant production. Results This project was funded in August 2024. Data collection began in April 2025. As of April 4, 2026, a total of 8 participants had been enrolled, and data analysis had not begun. Results are anticipated in 2027. Conclusions This study will use nonsedated MRI to investigate how velopharyngeal anatomy influences surgical decision-making and early speech outcomes. Such knowledge may be useful for presurgical planning and early monitoring of postsurgical speech outcomes in children with cleft palate. International Registered Report Identifier (IRRID) DERR1-10.2196/97206