Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants. (OT2SUITE)

Toulouse University Hospital

Status

Completed

Conditions

Prader-Willi Syndrome

Treatments

Drug: Oxytocin

Other: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT03081832

RC31/16/8407

2016-A01348-43 (Other Identifier)

Details and patient eligibility

About

The objective of this study is to collect data on tolerance and effects of early treatment with oxytocin in children with Prader Willi Syndrome aged from 3 to 4 years and to compare these infants with not treated age-matched infants with Prader Willi Syndrome.

Full description

In accordance with recommendations of regulatory authorities, we want to collect long term data of patients treated with oxytocin before the age of 6 months. Moreover clinical observations of these infants support long term effects on communication skills, global development and behaviour.

Enrollment

34 patients

Sex

All

Ages

3 to 4 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Infants with Prader Willi Syndrome (genetic diagnosis confirmed)
For treated group : infant included in the ancient study
For not treated group: infant never treated with oxytocin

Exclusion criteria

Subject involved in another search including an exclusion period still in progress at the time of inclusion.
Impossibility to give parents or legal guardian informed information
No coverage by a Social Security scheme
Refusal of parents or legal representative to sign consent.

If a patient has a contraindication to Magnetic resonance imaging, it may be included in the study but Magnetic resonance imaging will not be performed.