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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Evaluation of communication skills.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Oxytocin
Groups of children with Prader Willi Syndrome treated by oxytocin for 7 days during their first 6 months of life.
干预措施: Oxytocin (Drug)
Control
Groups of children with Prader Willi Syndrome not treated by oxytocin for 7 days during their first 6 months of life.
干预措施: Control (Other)
结局指标
主要结局
Evaluation of communication skills.
时间窗: Day 1
Assessed by Vineland-II scale.
次要结局
- Evaluation of global development.(Day 2 and 3)
- Evaluation of orality and eating behaviour.(Day 2)
- Evaluation of brain activity.(Day 3)
- Evaluation of plasma levels of ghrelin and other peptides involved in feeding behaviour or energy metabolism.(Day 1)
- Evaluation of adaptative behavior composite and 3 domains : "Daily living skills", "Socialization", "Motor skills".(Day 1)
- Evaluation of behavioral troubles.(Day 1)