NCT03081832

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

Long Term Evaluation of Infants Aged From 3 to 4 Years Old Included in the Ancient Study (Repeated Administrations of Oxytocin in Infants With Prader Willi Syndrome Aged From 0 to 6 Months) and Comparison With Not Treated and Age-matched Prader Willi Syndrome Infants (OT2SUITE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 3 Years – 4 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	Oxytocin	Infant included in the ancient study (repeated administrations of oxytocin in infants with Prader Willi Syndrome aged from 0 to 6 months)
OTHER	Control	Not treated.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-05-01
• Completion: 2018-12-01
• First posted: 2017-03-16
• Last updated: 2019-01-30

Locations

1 site across 1 country: France