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 : December 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prader-Willi Syndrome||Drug: Oxytocin Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Groups of children with Prader Willi Syndrome treated by oxytocin for 7 days during their first 6 months of life.
Infant included in the ancient study (repeated administrations of oxytocin in infants with Prader Willi Syndrome aged from 0 to 6 months)
Groups of children with Prader Willi Syndrome not treated by oxytocin for 7 days during their first 6 months of life.
- 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 ]
- 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...).
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
|Contact: Maïthé Tauber, Pr||5 34 55 85 51 ext email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Maïthé Tauber, Pr|
|Sub-Investigator: Gwenaëlle Diene, Dr|
|Sub-Investigator: Sophie Çabal-Berthoumieu, Dr|
|Sub-Investigator: Pascale Fichaux-Bourin, Dr|
|Principal Investigator:||Maïthé Tauber, Pr||Centre de référence du syndrome de Prader-Willi- CHU Toulouse|