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

CHU de TOULOUSE0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年4月15日

适应症

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, corrected age will be applied)
•- Signed informed consent obtained from the parents/holders of parental
•- Parents willing and able to comply with all study procedures.

•- 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 without medical insurance
•- Neonates or infants whose parents* situations may jeopardize the
•interpretation of the results
•- Neonate or infant with known hypersensitivity to oxytocin or the excipients
•of the product
•-Neonate or infant with concomitant treatment prolonging QT interval (cf. annex
•-. 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
•-. 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.

发起方

CHU de TOULOUSE