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

January 29, 2019 updated by: University Hospital, Toulouse

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Centre de référence du syndrome de Prader-Willi Hôpital des Enfants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 4 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oxytocin
Groups of children with Prader Willi Syndrome treated by oxytocin for 7 days during their first 6 months of life.
Drug: Oxytocin
Infant included in the ancient study (repeated administrations of oxytocin in infants with Prader Willi Syndrome aged from 0 to 6 months)
EXPERIMENTAL: Control
Groups of children with Prader Willi Syndrome not treated by oxytocin for 7 days during their first 6 months of life.
Other: Control
Not treated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of communication skills.
Time Frame: Day 1
Assessed by Vineland-II scale.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of adaptative behavior composite and 3 domains : "Daily living skills", "Socialization", "Motor skills".
Time Frame: Day 1
Assessed by Vineland-II scale.
Day 1
Evaluation of behavioral troubles.
Time Frame: Day 1
Assessed by Child Behaviour Check List questionnaire.
Day 1
Evaluation of global development.
Time Frame: Day 2 and 3
Assessed by Bayley Scales of Infant and Toddler Development.
Day 2 and 3
Evaluation of orality and eating behaviour.
Time Frame: Day 2

Assessed by:

  • A questionnaire on eating behavior.
  • An oral evaluation, which combines a clinical examination carried out by the reference center physician, and the assessment of eating behavior during the meal.
  • The fluoroscopy of swallowing.
Day 2
Evaluation of brain activity.
Time Frame: Day 3
Assessed by a morphological Magnetic resonance imaging, a resting functional Magnetic resonance imaging.
Day 3
Evaluation of plasma levels of ghrelin and other peptides involved in feeding behaviour or energy metabolism.
Time Frame: Day 1
Circulating levels of acylated and non-acylated ghrelin and some peptides and neuropeptides involved in appetite regulation (leptin, cortisol, insulin, Glucagon like peptide-1, pancreatic polypeptide, orexin A, alpha-melanocyte stimulating hormone...).
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Maïthé Tauber, Pr, Centre de référence du syndrome de Prader-Willi- CHU Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 10, 2017

First Posted (ACTUAL)

March 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/16/8407
  • 2016-A01348-43 (OTHER: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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