Tolerance of Intranasal Administration of OT in Prader-Willi Newborn Babies

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01548521
• Date of registration: 30/12/2011
• Prospective Registration: No
• Primary sponsor: University Hospital, Toulouse
• Public title: Tolerance of Intranasal Administration of OT in Prader-Willi Newborn Babies OTBB
• Scientific title: Tolerance of Intranasal Administration of OT in Prader-Willi Newborn Babies and Effect on Suck and Food Intake.
• Date of first enrolment: July 2011
• Target sample size: 5
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01548521
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

France

Contacts

• Name: Maithe TAUBER, MD
• Affiliation: Hospital of Toulouse

Key inclusion & exclusion criteria

Inclusion Criteria:

- neonates with genetic diagnosis of Prader-Willi syndrome

- aged from 15 days to 5 months

Exclusion Criteria:

- exclusive tube feeding

- arrhythmia



Age minimum: N/A
Age maximum: 5 Months
Gender: All

Health Condition(s) or Problem(s) studied

Prader-Willi Syndrome

Intervention(s)

Drug: Oxytocin

Primary Outcome(s)

Occurrence of adverse event, description and quantification of their severity, imputability to oxytocin administration. [Time Frame: up to day 8]

Secondary Outcome(s)

Evaluation of plasmatic OT, ghrelin and others neuroendocrine hormones involved in appetite regulation (leptin, cortisol, insulin, GLP-1, PYY, pancratic polypeptide, orexin A, aMSH) [Time Frame: from day 1 to month 3]

Quantitative evaluation of food intake [Time Frame: from day 1 to month 3]

Secondary ID(s)

10 152 02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors