Intranasal Oxytocin for Infants With Prader-Willi Syndrome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-01-04

Brief Summary

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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.

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Detailed Description

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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

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Prader-Willi Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

This will be a double-blinded study, as no studies to date have compared this treatment in infants with placebo. Board-certified speech and language pathologist who will be blinded to the treatment arm of each patient.

Study Groups

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Intranasal oxytocin

Intervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

4 IU/day of oxytocin administered via nasal spray device each morning.

IN-placebo

Intervention: 4 IU/day of placebo via nasal spray device each morning.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

4 IU/day of placebo administered via nasal spray device each morning

Interventions

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Oxytocin

4 IU/day of oxytocin administered via nasal spray device each morning.

Intervention Type DRUG

Placebo

4 IU/day of placebo administered via nasal spray device each morning

Intervention Type DRUG

Other Intervention Names

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Syntocinon Saline

Eligibility Criteria

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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.

Minimum Eligible Age

1 Week

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No