Oxytocin Treatment in Neonates and Infants With Prader-Willi Syndrome (OTBB3)
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| ClinicalTrials.gov Identifier: NCT04283578 |
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Recruitment Status :
Completed
First Posted : February 25, 2020
Last Update Posted : June 1, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prader-Willi Syndrome | Drug: OT Drug: Placebo comparator | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 52 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 |
| Actual Primary Completion Date : | October 16, 2021 |
| Actual Study Completion Date : | March 14, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Oxytocin
intranasal administration of OT
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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. |
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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. |
- 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
- Ghrelin dosage [ Time Frame: Day 0, Week 1 and week 4 ]Concentration of ghrelin (unacylated/UAG and acylated/AG)
- Oxytocin dosage [ Time Frame: Day 0, week 4 ]Plasma Oxytocin concentration
- 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: | 1 Day to 92 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female neonate or infant, with PWS genetically confirmed.
- 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).
- Signed informed consent obtained from the parents/holders of parental authority.
- Parents willing and able to comply with all study procedures.
Exclusion Criteria:
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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.
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
| Belgium | |
| Cliniques Saint Luc | |
| Bruxelles, Belgium | |
| France | |
| Hôpital Femme Mère Enfant | |
| Bron, France | |
| Hôpital Jeanne de Flandre | |
| Lille, France | |
| Hôpital de la Timone Enfant | |
| Marseille, France | |
| Groupe Hospitalier Necker - Enfants Malades | |
| Paris, France | |
| Centre de réfrence Prader-Willi, Hospital of infants | |
| Toulouse, France, 31059 | |
| Germany | |
| Klinik für Kinderheilkunde II | |
| Essen, Germany | |
| Principal Investigator: | Maithé TAUBER, MD | University Hospital, Toulouse |
| 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: | June 1, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 Overweight Overnutrition Nutrition Disorders Oxytocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs |