Oxytocin's long-term developmental impact in Prader-Willi Syndrome children tracked up to age four

Prader-Willi Syndrome (PWS) is a complex neurodevelopmental disorder characterized by severe hypotonia in infancy, followed by hyperphagia, obesity, and cognitive/behavioral challenges. Current management focuses on symptomatic treatment, but there's a significant unmet need for interventions addressing core neurodevelopmental deficits. Oxytocin (OT), a neuropeptide involved in social bonding and appetite regulation, has shown promise in early PWS interventions, potentially improving social cognition and feeding behaviors. This follow-up study aims to understand if early Oxytocin treatment yields sustained benefits into early childhood.

This study is an ongoing long-term follow-up, and as such, no results are available yet. The primary objective is to evaluate the sustained impact of early Oxytocin treatment (administered during the OTBB3 trial from 0 to 6 months) on the developmental trajectory of children with Prader-Willi Syndrome (PWS) up to 4 years of age. Researchers are collecting data on neurodevelopmental milestones, social interaction, feeding behaviors, and anthropometric measures. Specific outcomes being assessed include cognitive function, adaptive behaviors using standardized scales like the Bayley Scales of Infant Development and Vineland Adaptive Behavior Scales, and body composition. The study seeks to determine if early Oxytocin intervention leads to significant, lasting improvements in these domains compared to an age-matched untreated PWS cohort. The study's completion is estimated for April 2025, at which point initial findings on long-term outcomes are expected.