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Trial · NCT03245762

Intranasal Oxytocin for Infants With Prader-Willi Syndrome

NCT03245762, Phase 1, Phase 2, Completed, University of Florida; results first posted 2019-06-25

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Intranasal Oxytocin for Infants With Prader-Willi Syndrome. Trials, record NCT03245762. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03245762

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Intranasal Oxytocin for Infants With Prader-Willi Syndrome
NCT number
NCT03245762
Status
Completed
Phases
Phase 1, Phase 2
Enrollment
15 participants, actual
Lead sponsor
University of Florida
Conditions
Prader-Willi Syndrome
Interventions
Oxytocin, Placebo
First posted
2017-08-10
Last updated
2020-03-26
Results first posted
2019-06-25
Limitations and caveats
Short study with small number of participants

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySuck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1abaseline to day 5Swallow study Overall improvement

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYSuck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1abaseline to day 5ParticipantsCOUNT_OF_PARTICIPANTS

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1aIntranasal OxytocinImproved Competency8Participants
Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1aIN-placeboImproved Competency4Participants
Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1aIntranasal OxytocinNo Change in Competency'1Participants
Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1aIN-placeboNo Change in Competency'1Participants
Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1aIntranasal OxytocinWorsened Competency1Participants
Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1aIN-placeboWorsened Competency0Participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDIntranasal Oxytocin10
Overall StudySTARTEDIN-placebo5
Overall StudyCOMPLETEDIntranasal Oxytocin10
Overall StudyCOMPLETEDIN-placebo5
Overall StudyNOT COMPLETEDIntranasal Oxytocin0
Overall StudyNOT COMPLETEDIN-placebo0

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityIntranasal Oxytocin010
Total, all-cause mortalityIN-placebo05
Total, other adverse eventsIntranasal Oxytocin010
Total, other adverse eventsIN-placebo05
Total, serious adverse eventsIntranasal Oxytocin010
Total, serious adverse eventsIN-placebo05

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Intranasal Oxytocin vs IN-placebo: deaths from any causeTrial comparisons
Intranasal Oxytocin vs IN-placebo: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03245762

GET https://conductscience.org/api/trials/v1/NCT03245762/registered