Clinical Trial: Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 F

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 Summary: 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.
Sponsor: University Hospital, Toulouse

Current Primary Outcome: Evaluation of communication skills. [ Time Frame: Day 1 ]

Assessed by Vineland-II scale.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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...).


Original Secondary Outcome:

  • 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, peptide YY, pancreatic polypeptide, orexin A, alpha-MSH).


Information By: University Hospital, Toulouse

Dates:
Date Received: March 10, 2017
Date Started: January 2017
Date Completion: December 2018
Last Updated: May 2, 2017
Last Verified: May 2017