NCT04283578已完成3 期
Oxytocin Treatment in Neonates and Infants Aged From 0 to 3 Months With Prader-Willi Syndrome : a Study of Safety and Efficacy on Oral and Social Skills and Feeding Behavior of Intranasal Administration of Oxytocin vs Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 7
- 主要终点
- Neonatal Oral-Motor Assessment Scale (NOMAS) scale
研究概览
简要总结
Prospective, randomized, placebo-controlled, double-blind part of the phase III trial to assess the safety and efficacy of 4 weeks oxytocin (OT) administration on oral and social skills in neonates/infants with Prader-Willi Syndrome (PWS) aged less than 3 months at inclusion. Phase III clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 92 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female neonate or infant, with PWS genetically confirmed.
- •Age <92 days (plus a tolerance of up to 8 days maximum) (for preterm infants, born before 37 weeks amenorrhea, corrected age will be applied).
- •Signed informed consent obtained from the parents/holders of parental authority.
- •Parents willing and able to comply with all study procedures.
排除标准
- •Neonate or infant currently admitted to the emergency care unit for ongoing life-threatening comorbidities like severe respiratory, cardiovascular or neurological abnormalities.
- •Neonate or infant with prolongation of the QT interval.
- •Neonate or infant without medical insurance.
- •Neonate or infant with hypersensitivity to oxytocin or excipients of the product.
- •Neonate or infant with concomitant treatment prolonging QT interval
- •Neonate or infant with family history of genetic pathology causing QT interval prolongation.
- •Neonate or infant with hypokalemia (clinically relevant at the discretion of the doctor).
- •Neonate or infant participating simultaneously in another interventional study.
- •Neonates or infants whose parents' situations may jeopardize the interpretation of the results.
- •Neonates or infants whose parents' refuse video recording, required to respond to the primary objective of the study.
研究组 & 干预措施
Oxytocin
Experimental
intranasal administration of OT
干预措施: OT (Drug)
Oxytocin
Experimental
intranasal administration of OT
干预措施: Placebo comparator (Drug)
Placebo
Placebo Comparator
intranasal administration of placebo
干预措施: OT (Drug)
Placebo
Placebo Comparator
intranasal administration of placebo
干预措施: Placebo comparator (Drug)
结局指标
主要结局
Neonatal Oral-Motor Assessment Scale (NOMAS) scale
时间窗: 4 weeks
the score goes from 8 to 28, the higher the score meaning a worse outcome
次要结局
- Ghrelin dosage(Day 0, Week 1 and week 4)
- Oxytocin dosage(Day 0, week 4)
- Proficiency score(Day 0, Week and week 4)
研究者
研究点 (7)
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