Intranasal Oxytocin for Infants With Prader-Willi Syndrome
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|ClinicalTrials.gov Identifier: NCT03245762|
Recruitment Status : Completed
First Posted : August 10, 2017
Results First Posted : June 25, 2019
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prader-Willi Syndrome||Drug: Oxytocin Drug: Placebo||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Masking Description:||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.|
|Primary Purpose:||Basic Science|
|Official Title:||Intranasal Oxytocin for Treatment of Infants and Children With Prader-Willi Syndrome in Nutritional Phase 1a - Phase 2 Study|
|Actual Study Start Date :||August 1, 2017|
|Actual Primary Completion Date :||January 4, 2018|
|Actual Study Completion Date :||January 4, 2018|
Active Comparator: Intranasal oxytocin
Intervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.
4 IU/day of oxytocin administered via nasal spray device each morning.
Other Name: Syntocinon
Placebo Comparator: IN-placebo
Intervention: 4 IU/day of placebo via nasal spray device each morning.
4 IU/day of placebo administered via nasal spray device each morning
Other Name: Saline
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245762
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Jennifer Miller, MD||University of Florida|