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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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ClinicalTrials.gov Identifier: NCT03081832
Recruitment Status : Recruiting
First Posted : March 16, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Prader-Willi Syndrome Drug: Oxytocin Other: Control Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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.
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.
Other: Control
Not treated.




Primary Outcome Measures :
  1. Evaluation of communication skills. [ Time Frame: Day 1 ]
    Assessed by Vineland-II scale.


Secondary Outcome Measures :
  1. Evaluation of adaptative behavior composite and 3 domains : "Daily living skills", "Socialization", "Motor skills". [ Time Frame: Day 1 ]
    Assessed by Vineland-II scale.

  2. Evaluation of behavioral troubles. [ Time Frame: Day 1 ]
    Assessed by Child Behaviour Check List questionnaire.

  3. Evaluation of global development. [ Time Frame: Day 2 and 3 ]
    Assessed by Bayley Scales of Infant and Toddler Development.

  4. 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.

  5. Evaluation of brain activity. [ Time Frame: Day 3 ]
    Assessed by a morphological Magnetic resonance imaging, a resting functional Magnetic resonance imaging.

  6. 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
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.


Information from the National Library of Medicine

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


Contacts
Contact: Maïthé Tauber, Pr 5 34 55 85 51 ext 33 tauber.mt@chu-toulouse.fr

Locations
France
Centre de référence du syndrome de Prader-Willi Hôpital des Enfants Recruiting
Toulouse, France, 31059
Contact: Maïthé Tauber, Pr    5 34 55 85 51 ext 33    tauber.mt@chu-toulouse.fr   
Principal Investigator: Maïthé Tauber, Pr         
Sub-Investigator: Gwenaëlle Diene, Dr         
Sub-Investigator: Sophie Çabal-Berthoumieu, Dr         
Sub-Investigator: Pascale Fichaux-Bourin, Dr         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Maïthé Tauber, Pr Centre de référence du syndrome de Prader-Willi- CHU Toulouse

Publications:

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03081832     History of Changes
Other Study ID Numbers: 16/8407
2016-A01348-43 ( Other Identifier: ID-RCB )
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
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

Keywords provided by University Hospital, Toulouse:
Prader-Willi
Oxytocin
Communication skills
Oral skills
Brain activity
Hormonal disease

Additional relevant MeSH terms:
Intellectual Disability
Syndrome
Prader-Willi Syndrome
Hyperphagia
Disease
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs