NCT03245762

Intranasal Oxytocin for Infants With Prader-Willi Syndrome

Intranasal Oxytocin for Treatment of Infants and Children With Prader-Willi Syndrome in Nutritional Phase 1a - Phase 2 Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 1 Week – 6 Months
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	Oxytocin	4 IU/day of oxytocin administered via nasal spray device each morning.
DRUG	Placebo	4 IU/day of placebo administered via nasal spray device each morning

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-01-04
• Completion: 2018-01-04
• First posted: 2017-08-10
• Last updated: 2020-03-26
• Results posted: 2019-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study