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)

Phase 3

Withdrawn

• Conditions: Prader-Willi-syndrome; rare gentic disease; 10029299; 10021605; 10028920

• Registration Number: NL-OMON55101
• Lead Sponsor: CHU de TOULOUSE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

- 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
authority
- Parents willing and able to comply with all study procedures.

Exclusion Criteria

- 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
16).
-. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified