WIP 48 - Pharyngoesophageal Reflexes in Extremely Premature Infants

Publication Number: WIP 48.7425

Darah Yuhas, Johns Hopkins All Children's Hospital, St. Petersburg, FL, United States; Preceous S. Jensen, Johns Hopkins All Children's Hospital, St Petersburg, FL, United States

Background: The pathophysiology of dysphagia in the extremely premature population is multi-factorial and not fully understood. The gold standard for diagnosing esophageal dysmotility in pediatrics is high resolution manometry (HRM). HRM has been shown to be safe, feasible and well-tolerated in the neonatal population. However, the pharyngoesophageal reflexes of infants born < 28 weeks gestation have not been fully characterized.

Objective: To characterize pharyngoesophageal reflexes across maturation in extremely premature infants < 28 weeks gestation at birth

Design/Methods: This is a single-center, prospective cohort of premature infants < 28 weeks gestation in the Johns Hopkins All Children’s Hospital (JHACH) NICU. Manometry will be performed at three distinct intervals (37-38 weeks, 40-42 weeks and at ≥ 44 weeks PMA). The primary outcome is the presence of a pharyngeal reflexive swallowing response. If present, HRM data analyzing the integrity of the swallow will be analyzed as secondary outcomes. Patients are included if born at < 28 weeks gestational age and admitted to the JHACH NICU within 72 hours of birth. Patients are excluded if diagnosed with esophageal or upper airway anomalies, chromosomal anomalies or death before study date. Power and sample size were examined using PASS 16 Power Analysis and Sample Size Software with significance set at .05. We expect 60 patients to be eligible for the study over 18 months, and plan to recruit 30 patients. We anticipate that 50% will have a pharyngeal swallow within 5 seconds of pharyngeal infusion. We will have the ability to produce a two-sided 95% confidence interval for the population proportion with a precision of ± 0.187. Continuous variables will be summarized as means with standard deviations. Categorical variables will be summarized as counts with percentages and compared using the Chi-square test or Fisher’s exact test as appropriate. This project received initial IRB approval In June of 2023. To date, 6 patients have been recruited for this study and we project to recruit 3 patients per month over the next 6 months.