Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants. (OT2SUITE)
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ClinicalTrials.gov Identifier: NCT03081832 |
Recruitment Status :
Completed
First Posted : March 16, 2017
Last Update Posted : January 30, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prader-Willi Syndrome | Drug: Oxytocin Other: Control | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Long Term Evaluation of Infants Aged From 3 to 4 Years Old Included in the Ancient Study (Repeated Administrations of Oxytocin in Infants With Prader Willi Syndrome Aged From 0 to 6 Months) and Comparison With Not Treated and Age-matched Prader Willi Syndrome Infants (OT2SUITE) |
Actual Study Start Date : | January 2017 |
Actual Primary Completion Date : | May 2018 |
Actual Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Oxytocin
Groups of children with Prader Willi Syndrome treated by oxytocin for 7 days during their first 6 months of life.
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Drug: Oxytocin
Infant included in the ancient study (repeated administrations of oxytocin in infants with Prader Willi Syndrome aged from 0 to 6 months) |
Experimental: Control
Groups of children with Prader Willi Syndrome not treated by oxytocin for 7 days during their first 6 months of life.
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Other: Control
Not treated. |
- Evaluation of communication skills. [ Time Frame: Day 1 ]Assessed by Vineland-II scale.
- Evaluation of adaptative behavior composite and 3 domains : "Daily living skills", "Socialization", "Motor skills". [ Time Frame: Day 1 ]Assessed by Vineland-II scale.
- Evaluation of behavioral troubles. [ Time Frame: Day 1 ]Assessed by Child Behaviour Check List questionnaire.
- Evaluation of global development. [ Time Frame: Day 2 and 3 ]Assessed by Bayley Scales of Infant and Toddler Development.
- Evaluation of orality and eating behaviour. [ Time Frame: Day 2 ]
Assessed by:
- A questionnaire on eating behavior.
- An oral evaluation, which combines a clinical examination carried out by the reference center physician, and the assessment of eating behavior during the meal.
- The fluoroscopy of swallowing.
- Evaluation of brain activity. [ Time Frame: Day 3 ]Assessed by a morphological Magnetic resonance imaging, a resting functional Magnetic resonance imaging.
- Evaluation of plasma levels of ghrelin and other peptides involved in feeding behaviour or energy metabolism. [ Time Frame: Day 1 ]Circulating levels of acylated and non-acylated ghrelin and some peptides and neuropeptides involved in appetite regulation (leptin, cortisol, insulin, Glucagon like peptide-1, pancreatic polypeptide, orexin A, alpha-melanocyte stimulating hormone...).

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Ages Eligible for Study: | 3 Years to 4 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Infants with Prader Willi Syndrome (genetic diagnosis confirmed)
- For treated group : infant included in the ancient study
- For not treated group: infant never treated with oxytocin
Exclusion Criteria:
- Subject involved in another search including an exclusion period still in progress at the time of inclusion.
- Impossibility to give parents or legal guardian informed information
- No coverage by a Social Security scheme
- Refusal of parents or legal representative to sign consent.
If a patient has a contraindication to Magnetic resonance imaging, it may be included in the study but Magnetic resonance imaging will not be performed.

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): NCT03081832
France | |
Centre de référence du syndrome de Prader-Willi Hôpital des Enfants | |
Toulouse, France, 31059 |
Principal Investigator: | Maïthé Tauber, Pr | Centre de référence du syndrome de Prader-Willi- CHU Toulouse |
Responsible Party: | University Hospital, Toulouse |
ClinicalTrials.gov Identifier: | NCT03081832 |
Other Study ID Numbers: |
RC31/16/8407 2016-A01348-43 ( Other Identifier: ID-RCB ) |
First Posted: | March 16, 2017 Key Record Dates |
Last Update Posted: | January 30, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Prader-Willi Oxytocin Communication skills |
Oral skills Brain activity Hormonal disease |
Prader-Willi Syndrome Syndrome Disease Pathologic Processes Intellectual Disability Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Abnormalities, Multiple Congenital Abnormalities |
Chromosome Disorders Genetic Diseases, Inborn Obesity Overnutrition Nutrition Disorders Oxytocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs |