Intranasal Oxytocin
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StatusAccepting Candidates
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Age1 Week - 6 Months
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SexesAll
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Healthy VolunteersNo
Objective
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.
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.
Details
Full study title | Intranasal Oxytocin for Treatment of Infants and Children with Prader-Willi Syndrome in Nutritional Phase 1a |
Protocol number | OCR16237 |
ClinicalTrials.gov ID | NCT03245762 |
Phase | Phase 1/Phase 2 |
Eligibility
Inclusion Criteria:
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.
Exclusion Criteria:
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.