Status:
COMPLETED
Oxytocin Treatment in Neonates and Infants With Prader-Willi Syndrome
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
International Clinical Trials Association
Epidemiological and Clinical Research Information Network
Conditions:
Prader-Willi Syndrome
Eligibility:
All Genders
1-92 years
Phase:
PHASE3
Brief Summary
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/in...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 1\. Neonate or infant currently admitted to the emergency care unit for ongoing life-threatening comorbidities like severe respiratory, cardiovascular or neurological abnormalities.
- 2\. Neonate or infant with prolongation of the QT interval. 3. Neonate or infant without medical insurance. 4. Neonate or infant with hypersensitivity to oxytocin or excipients of the product.
- 5\. Neonate or infant with concomitant treatment prolonging QT interval 6. Neonate or infant with family history of genetic pathology causing QT interval prolongation.
- 7\. Neonate or infant with hypokalemia (clinically relevant at the discretion of the doctor).
- 8\. Neonate or infant participating simultaneously in another interventional study.
- 9\. Neonates or infants whose parents' situations may jeopardize the interpretation of the results.
- 10\. Neonates or infants whose parents' refuse video recording, required to respond to the primary objective of the study.
Key Trial Info
Start Date :
March 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04283578
Start Date
March 10 2020
End Date
March 14 2022
Last Update
June 1 2023
Active Locations (7)
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1
Cliniques Saint Luc
Brussels, Belgium
2
Hôpital Femme Mère Enfant
Bron, France
3
Hôpital Jeanne de Flandre
Lille, France
4
Hôpital de la Timone Enfant
Marseille, France