Intranasal Oxytocin for Infants With Prader-Willi Syndrome

Status Completed

Clinical Trial Summary

The purpose of this study is to compare the change in suck and swallow competency from baseline to morning of day 6 with intranasal oxytocin spray vs placebo in infants/children with Prader-Willi Syndrome who are in nutritional phase 1a. Videofluoroscopic swallow studies will be performed on treatment day 1 and on the day following treatment morning of day 6.

Clinical Trial Description

The overall objective of this Phase 2 trial is to compare the change from baseline to morning of day 6 of Internasal Oxytocin (IN-OT) on suck and swallow competency in infants/children with Prader-Willi Syndrome (PWS) who are in nutritional phase 1a.

Study Hypothesis 1: The Study team hypothesize that replacing Oxytocin (OT) in infants and children who are in nutritional phase 1a will improve their suck and swallow, potentially even eliminating the need for gastrostomy tubes and nasogastric tubes for feeding, and decreasing the risk of aspiration with oral feeding.

Study Hypothesis 2: The Study team hypothesize that replacing OT in infants and children with PWS will result in improved eye contact, daytime alertness, and feelings of bonding between the parents and the infant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03245762
Study type	Interventional
Source	University of Florida
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	August 1, 2017
Completion date	January 4, 2018

View Details

See also
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