Intranasal Oxytocin for Infants With Prader-Willi Syndrome

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.

Inclusion Criteria:

1. Individuals with genetically confirmed PWS who are in nutritional phase 1a, as
determined by PI

2. Physical exam and laboratory results that are within the normal range.

3. Presence of a parent/caregiver/guardian that is able to consent for their
participation.

Exclusion Criteria:

1. Exposure to any investigational agent in the 30 days prior to randomization.

2. Prior chronic treatment with oxytocin.

3. A medical condition that might interfere with the conduct of the study, confound
interpretation of study results or endanger the subject's well-being.