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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 May 2016
Main ID:  NCT02529085
Date of registration: 24/04/2015
Prospective Registration: No
Primary sponsor: University Hospital, Toulouse
Public title: PWS European Blood Bank for Infants and Controls From 0 to 48 Months
Scientific title: Study of Early Endocrine Profile in Infants With Prader-Willi Syndrome (PWS) in Order to Unravel the Switch From Early Feeding Difficulties to Obesity and Hyperphagia.
Date of first enrolment: March 2013
Target sample size: 500
Recruitment status: Recruiting
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science  
Phase:  N/A
Countries of recruitment
Belgium France Germany Netherlands Sweden United Kingdom
Name:     Maithe TAUBER, MD
Telephone: 534558551
Name:     Maithe TAUBER, MD
Affiliation:  University Hospital, Toulouse
Key inclusion & exclusion criteria

Inclusion Criteria (PWS infants cohort)

- Genetic diagnosis of Prader-Willi syndrome

Exclusion Criteria (PWS infants cohort)

Inclusion Criteria (control group)

- children hospitalized for a planned surgery for malformation, orthopaedic or visceral

Exclusion Criteria (control group)

- children with endocrine disorder

Age minimum: N/A
Age maximum: 18 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Prader-Willi Syndrome
Other: blood samples
Primary Outcome(s)
Levels of hormones and neuropeptides [Time Frame: 42 months]
Secondary Outcome(s)
Correlation between hormones and neuropeptides levels [Time Frame: 42 months]
Secondary ID(s)
12 359 03
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
European Society for Paediatric Endocrinology
Results available:
Date Posted:
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