Oxytocin treatment in neonates and infants aged from 0 to 3 months with prader-willi syndrome

Phase 1

• Conditions: Prader-Willi Syndrom; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2019-002385-12-NL
• Lead Sponsor: niversity Hospital of Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-08
• Last Update Posted: 12 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

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 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

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified