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Intranasal Oxytocin for Infants With Prader-Willi Syndrome

NCT03245762 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-03-26

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Prader-Willi Syndrome Association

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Jennifer Miller, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2018-01-04
Completion
2018-01-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03245762 on ClinicalTrials.gov