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Completed

NCT Number: NCT03245762

Intranasal Oxytocin for Infants With Prader-Willi Syndrome

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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Key information

Conditions

Prader-Willi Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight

Age range

1 week–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxytocin

Drug

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

Other names: Syntocinon

Placebo

Drug

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

Other names: Saline

Primary outcomes

  1. Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a

    Time frame: baseline to day 5

    Swallow study Overall improvement

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Prader-Willi Syndrome Association

Registry information

Official study title

Intranasal Oxytocin for Treatment of Infants and Children With Prader-Willi Syndrome in Nutritional Phase 1a - Phase 2 Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2017
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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