PWSA (USA) would like to thank all of the generous donors who contributed to the Association towards oxytocin research. You have made this – and future clinical trials on oxytocin possible.
Phase 2 Study: Intranasal Oxytocin for Treatment of Infants with Prader-Willi Syndrome in Nutritional Phase 1a
Principal Investigator: Jennifer Miller, MD
Pediatric Endocrinology, University of Florida
Abstract
Individuals with Prader-Willi syndrome (PWS) experience several nutritional phases through their lifespan. Initially, there is severe neonatal hypotonia with decreased appetite and impaired suck necessitating assisted feeding (nutritional phase 1a) (Miller et al, 2011). Nutritional phase 1a is characterized by the need for assisted feeding. The feeding can typically be accomplished using a special nipple/bottle, placement of a nasogastric tube, or placement of a gastrostomy tube.However, this is a dangerous time for infants with PWS, and has a high rate of morbidity and mortality due to aspiration and respiratory failure (Nagai et al, 2005). Feeding and swallowing skill development parallels psychosocial milestones of homeostasis, attachment, and separation/individuation. Mothers of infants with PWS often describe a feeling of lack of attachment or lack of bonding with their child due to the lack of suckling and responsiveness of the children.
In an open-label study, oxytocin nasal spray has been shown to be well-tolerated in infants with PWS and to improve feeding and social skills (Tauber et al, 2017). In this study we want to test whether daily oxytocin nasal spray will perform superiorly to placebo in improving suck, swallow, feeding, and maternal bonding in individuals with PWS who are in nutritional phase 1a. The results of this study will help determine if a larger, future trial should be done to consider intranasal oxytocin as standard of care for individuals with PWS in nutritional phase 1a. Clinical trials of intranasal oxytocin for food-related behaviors in older children will be forthcoming in the future.
Jennifer Bolander has been serving as a Special Education Specialist for PWSA (USA) since October of 2015. She is a graduate of John Carroll University and lives in Ohio with her husband Brad and daughters Kate (17), and Sophia (13) who was born with PWS.
Perry A. Zirkel has written more than 1,500 publications on various aspects of school law, with an emphasis on legal issues in special education. He writes a regular column for NAESP’s Principal magazine and NASP’s Communiqué newsletter, and he did so previously for Phi Delta Kappan and Teaching Exceptional Children.
Evan has worked with the Prader-Willi Syndrome Association (USA) since 2007 primarily as a Crisis Intervention and Family Support Counselor. Evans works with parents and schools to foster strong collaborative relationships and appropriate educational environments for students with PWS.
Dr. Amy McTighe is the PWS Program Manager and Inpatient Teacher at the Center for Prader-Willi Syndrome at the Children’s Institute of Pittsburgh. She graduated from Duquesne University receiving her Bachelor’s and Master’s degree in Education with a focus on elementary education, special education, and language arts.
Staci Zimmerman works for Prader-Willi Syndrome Association of Colorado as an Individualized Education Program (IEP) consultant. Staci collaborates with the PWS multi-disciplinary clinic at the Children’s Hospital in Denver supporting families and school districts around the United States with their child’s Individual Educational Plan.
Founded in 2001, SDLC is a non-profit legal services organization dedicated to protecting and advancing the legal rights of people with disabilities throughout the South. It partners with the Southern Poverty Law Center, Protection and Advocacy (P&A) programs, Legal Services Corporations (LSC) and disability organizations on major, systemic disability rights issues involving the Individuals with Disabilities Education Act (IDEA), Americans with Disabilities Act (ADA), and the federal Medicaid Act. Recently in November 2014, Jim retired.