Clinical Research Directory
Browse clinical research sites, groups, and studies.
Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial
Sponsor: University Hospital, Toulouse
Summary
This study is a prospective, multicentre, interventional cohort study in children with Prader-Willi Syndrome (PWS) over 4 years (no treatment administered). The duration of the preceding OTTB3 study is 26 weeks. An untreated cohort of children with PWS will be included at an age of 2 years and followed up until an age of 4 years. Regarding the untreated cohort, children with PWS born in France and too old to be recruited in OTBB3 trial, principally those who were born within one year before the start of OTBB3 trial, will be offered to participate in this study. Infants born later who couldn't be included in OTBB3 study will be also offered to participate.
Official title: Long-term Interventional Follow-up Study up to 4 Years of Age of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial and Comparison With an Untreated Cohort of Children With Prader-Willi Syndrome
Key Details
Gender
All
Age Range
12 Months - 36 Months
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2021-09-07
Completion Date
2025-04-01
Last Updated
2024-04-30
Healthy Volunteers
No
Conditions
Interventions
Follow-up study of the treated cohort
follow-up study of the patients in the treated cohort: that have been included in the otbb3 study
Follow-up study of the untreated cohort
follow-up study of the patients in the untreated cohort: that have NOT been included in the otbb3 study
Locations (12)
Hôpital Femme Mère Enfant
Bron, France
CHU Dijon Hôpital des Enfants
Dijon, France
CHU de Grenoble
Grenoble, France
Hôpital Jeanne de Flandre
Lille, France
Hôpital de la Timone Enfant
Marseille, France
CHU Nancy
Nancy, France
CHU Nantes
Nantes, France
Hôpital CHU-Lenval
Nice, France
Groupe Hospitalier Necker - Enfants Malades
Paris, France
CHU Rennes
Rennes, France
CHU Rouen
Rouen, France
Centre de réfrence Prader-Willi, Hospital of infants
Toulouse, France