Intranasal Oxytocin for Infants With Prader-Willi Syndrome

What Was Tested

The trial (phase 1, phase 2) is built around Oxytocin.

Videofluoroscopic swallow studies will be performed on treatment day 1 and on the day following treatment morning of day 6.

It had two arms (groups): Intranasal oxytocin (active comparator) and IN-placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 15 actual participants took part.

It was open to people of any sex aged from 1 Week up to 6 months.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Individuals with genetically confirmed PWS who are in nutritional phase 1a, as determined by PI. Physical exam and laboratory results that are within the normal range. Presence of a parent/caregiver/guardian that is able to consent for their participation.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: exposure to any investigational agent in the 30 days prior to randomization; prior chronic treatment with oxytocin; A medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger the subject's well-being.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Oxytocin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: care provider and outcomes assessor.

It started in 2017-08-01 with completion listed for 2018-01-04.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a (time frame: baseline to day 5).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Oxytocin in 15 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.