Prospective, randomized, placebo-controlled, double-blind part of the phase III trial to assess the safety and efficacy of 4 weeks oxytocin (OT) administration on oral and social skills in neonates/infants with Prader-Willi Syndrome (PWS) aged less than 3 months at inclusion. Phase III clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
One group will receive OT for 4 weeks, then placebo or OT for 8 weeks
One group will receive Placebo for 4 weeks, then Placebo or OT for 8 weeks.
Cliniques Saint Luc
Brussels, Belgium
Hôpital Femme Mère Enfant
Bron, France
Hôpital Jeanne de Flandre
Lille, France
Hôpital de la Timone Enfant
Marseille, France
Neonatal Oral-Motor Assessment Scale (NOMAS) scale
the score goes from 8 to 28, the higher the score meaning a worse outcome
Time frame: 4 weeks
Ghrelin dosage
Concentration of ghrelin (unacylated/UAG and acylated/AG)
Time frame: Day 0, Week 1 and week 4
Oxytocin dosage
Plasma Oxytocin concentration
Time frame: Day 0, week 4
Proficiency score
The volume of milk taken in the first five minutes of feeding
Time frame: Day 0, Week and week 4
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Groupe Hospitalier Necker - Enfants Malades
Paris, France
Centre de réfrence Prader-Willi, Hospital of infants
Toulouse, France
Klinik für Kinderheilkunde II
Essen, Germany