Oxytocin Treatment in Neonates and Infants With Prader-Willi Syndrome

Oxytocin Treatment in Neonates and Infants Aged From 0 to 3 Months With Prader-Willi Syndrome : a Study of Safety and Efficacy on Oral and Social Skills and Feeding Behavior of Intranasal Administration of Oxytocin vs Placebo

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04283578

Acronym

OTBB3

Enrollment

Registered

2020-02-25

Start date

2020-03-10

Completion date

2022-03-14

Last updated

2023-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prader-Willi Syndrome

Brief summary

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.

Interventions

DRUGOT

One group will receive OT for 4 weeks, then placebo or OT for 8 weeks

DRUGPlacebo comparator

One group will receive Placebo for 4 weeks, then Placebo or OT for 8 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 92 Days

Healthy volunteers

Inclusion criteria

1. Male or female neonate or infant, with PWS genetically confirmed. 2. Age \<92 days (plus a tolerance of up to 8 days maximum) (for preterm infants, born before 37 weeks amenorrhea, corrected age will be applied). 3. Signed informed consent obtained from the parents/holders of parental authority. 4. Parents willing and able to comply with all study procedures.

Exclusion criteria

* 1\. Neonate or infant currently admitted to the emergency care unit for ongoing life-threatening comorbidities like severe respiratory, cardiovascular or neurological abnormalities. 2\. Neonate or infant with prolongation of the QT interval. 3. Neonate or infant without medical insurance. 4. Neonate or infant with hypersensitivity to oxytocin or excipients of the product. 5\. Neonate or infant with concomitant treatment prolonging QT interval 6. Neonate or infant with family history of genetic pathology causing QT interval prolongation. 7\. Neonate or infant with hypokalemia (clinically relevant at the discretion of the doctor). 8\. Neonate or infant participating simultaneously in another interventional study. 9\. Neonates or infants whose parents' situations may jeopardize the interpretation of the results. 10\. Neonates or infants whose parents' refuse video recording, required to respond to the primary objective of the study.

Design outcomes

Primary

Measure	Time frame	Description
Neonatal Oral-Motor Assessment Scale (NOMAS) scale	4 weeks	the score goes from 8 to 28, the higher the score meaning a worse outcome

Secondary

Measure	Time frame	Description
Ghrelin dosage	Day 0, Week 1 and week 4	Concentration of ghrelin (unacylated/UAG and acylated/AG)
Oxytocin dosage	Day 0, week 4	Plasma Oxytocin concentration
Proficiency score	Day 0, Week and week 4	The volume of milk taken in the first five minutes of feeding

Countries

Belgium, France, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026