Clinical trial NCT03081832: Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants.
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prader-Willi Syndrome
Keywords: Prader-Willi
Oxytocin
Communication skills
Oral skills
Brain activity
Hormonal disease
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-03-16
Enrollment: 34
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to collect data on tolerance and effects of early treatment with oxytocin in children with Prader Willi Syndrome aged from 3 to 4 years and to compare these infants with not treated age-matched infants with Prader Willi Syndrome.

Detailed description: In accordance with recommendations of regulatory authorities, we want to collect long term data of patients treated with oxytocin before the age of 6 months. Moreover clinical observations of these infants support long term effects on communication skills, global development and behaviour.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of communication skills.
timeFrame: Day 1
Secondary outcomes:
measure: Evaluation of adaptative behavior composite and 3 domains : "Daily living skills", "Socialization", "Motor skills".
timeFrame: Day 1
measure: Evaluation of behavioral troubles.
timeFrame: Day 1
measure: Evaluation of global development.
timeFrame: Day 2 and 3
measure: Evaluation of orality and eating behaviour.
timeFrame: Day 2
measure: Evaluation of brain activity.
timeFrame: Day 3
measure: Evaluation of plasma levels of ghrelin and other peptides involved in feeding behaviour or energy metabolism.
timeFrame: Day 1
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Centre de référence du syndrome de Prader-Willi Hôpital des Enfants
Study officials:
affiliation: Centre de référence du syndrome de Prader-Willi- CHU Toulouse
name: Maïthé Tauber, Pr
role: PRINCIPAL_INVESTIGATOR
References:
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