OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL) - OTBB3

niversity Hospital of Toulouse0 个研究点目标入组 48 人开始时间: 2021年4月21日最近更新: 2022年5月9日

试验速览

暂无简介。

•- 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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 48
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Neonate or infant 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 with hypokaliema
•- Neonate or infant without medical insurance
•- Neonates or infants whose parents’ situations may jeopardize the interpretation of the results
•- Neonate or infant with known hypersensitivity to the excipients of the product
•- Neonate or infant participating simultaneously in another interventional study.

发起方

niversity Hospital of Toulouse