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 ]
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