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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03081832 |
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Date of registration:
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10/03/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants.
OT2SUITE |
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Scientific title:
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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) |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03081832 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Maïthé Tauber, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre de référence du syndrome de Prader-Willi- CHU Toulouse |
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Key inclusion & exclusion criteria
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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.
Age minimum:
3 Years
Age maximum:
4 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Prader-Willi Syndrome
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Intervention(s)
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Other: Control
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Drug: Oxytocin
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Primary Outcome(s)
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Evaluation of communication skills.
[Time Frame: Day 1]
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Secondary Outcome(s)
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Evaluation of plasma levels of ghrelin and other peptides involved in feeding behaviour or energy metabolism.
[Time Frame: Day 1]
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Evaluation of adaptative behavior composite and 3 domains : "Daily living skills", "Socialization", "Motor skills".
[Time Frame: Day 1]
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Evaluation of brain activity.
[Time Frame: Day 3]
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Evaluation of global development.
[Time Frame: Day 2 and 3]
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Evaluation of orality and eating behaviour.
[Time Frame: Day 2]
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Evaluation of behavioral troubles.
[Time Frame: Day 1]
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Secondary ID(s)
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RC31/16/8407
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2016-A01348-43
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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