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Completed

NCT Number: NCT03081832

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

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.

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Key information

Conditions

Prader-Willi Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight

Age range

3 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de référence du syndrome de Prader-Willi Hôpital des Enfants

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxytocin

Drug

Infant included in the ancient study (repeated administrations of oxytocin in infants with Prader Willi Syndrome aged from 0 to 6 months)

Control

Other

Not treated.

Primary outcomes

  1. Evaluation of communication skills.

    Time frame: Day 1

    Assessed by Vineland-II scale.

Secondary outcomes

  1. Evaluation of adaptative behavior composite and 3 domains : "Daily living skills", "Socialization", "Motor skills".

    Time frame: Day 1

    Assessed by Vineland-II scale.

  2. Evaluation of behavioral troubles.

    Time frame: Day 1

    Assessed by Child Behaviour Check List questionnaire.

  3. Evaluation of global development.

    Time frame: Day 2 and 3

    Assessed by Bayley Scales of Infant and Toddler Development.

  4. 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.

  5. Evaluation of brain activity.

    Time frame: Day 3

    Assessed by a morphological Magnetic resonance imaging, a resting functional Magnetic resonance imaging.

  6. 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...).

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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)

Acronym: OT2SUITE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 16, 2017
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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