Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial
NCT ID: NCT05032326
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
80 participants
INTERVENTIONAL
2021-09-07
2025-04-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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OXYTOCIN (OT) Treated cohort
babies treated with Oxytocin during the OTBB3 study
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
Untreated cohort
babies not included in the OTBB3 study and therefore never treated with Oxytocin
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. The parents (or legal representative) must have signed the consent form;
3. Treated cohort: the child participated in the OTBB3 study and is aged 16±4 months at inclusion,
4. Untreated cohort: the child has never received OT, is aged 30±6 months at inclusion (in order to maximise the number of children in the untreated cohort) and is followed in France.
Exclusion Criteria
1. Inability for the parents (or legal representative) to understand/fulfil study requirements;
2. No coverage by a social security regime;
2. Refusal of parents (or legal representative) to sign the consent form;
12 Months
36 Months
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Maithé TAUBER, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC31/20/0421
Identifier Type: -
Identifier Source: org_study_id
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