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Oxytocin Treatment in Neonates and Infants With Prader-Willi Syndrome (OTBB3)

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ClinicalTrials.gov Identifier: NCT04283578
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : January 29, 2021
Sponsor:
Collaborators:
International Clinical Trials Association
Epidemiological and Clinical Research Information Network
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Prader-Willi Syndrome Drug: OT Drug: Placebo comparator Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 10, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin
intranasal administration of OT
Drug: OT
One group will receive OT for 4 weeks, then placebo or OT for 8 weeks
Other Name: oxytocin

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

Placebo Comparator: Placebo
intranasal administration of placebo
Drug: OT
One group will receive OT for 4 weeks, then placebo or OT for 8 weeks
Other Name: oxytocin

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




Primary Outcome Measures :
  1. Neonatal Oral-Motor Assessment Scale (NOMAS) scale [ Time Frame: 4 weeks ]
    the score goes from 8 to 28, the higher the score meaning a worse outcome


Secondary Outcome Measures :
  1. Ghrelin dosage [ Time Frame: Day 0, Week 1 and week 4 ]
    Concentration of ghrelin (unacylated/UAG and acylated/AG)

  2. Oxytocin dosage [ Time Frame: Day 0, week 4 ]
    Plasma Oxytocin concentration

  3. Proficiency score [ Time Frame: Day 0, Week and week 4 ]
    The volume of milk taken in the first five minutes of feeding



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Ages Eligible for Study:   up to 92 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283578


Contacts
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Contact: Maithé TAUBER, MD 33-561778771 tauber.mt@chu-toulouse.fr
Contact: Nadège ALGANS 33-561778771 algans.n@chu-toulouse.fr

Locations
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France
Hospital of Toulouse Recruiting
Toulouse, France, 31059
Contact: Maithe TAUBER         
Sponsors and Collaborators
University Hospital, Toulouse
International Clinical Trials Association
Epidemiological and Clinical Research Information Network
Investigators
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Principal Investigator: Maithé TAUBER, MD University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04283578    
Other Study ID Numbers: RC31/15/7825
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prader-Willi Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs