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NCT Number: NCT04283578

Oxytocin Treatment in Neonates and Infants With Prader-Willi Syndrome

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.

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Key information

Conditions

Prader-Willi Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight

Age range

1 day–92 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cliniques Saint Luc, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 1. Neonate or infant currently admitted to the emergency care unit for ongoing life-threatening comorbidities like severe respiratory, cardiovascular or neurological abnormalities.
  • 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.
  • Neonate or infant with concomitant treatment prolonging QT interval 6. Neonate or infant with family history of genetic pathology causing QT interval prolongation.
  • Neonate or infant with hypokalemia (clinically relevant at the discretion of the doctor).
  • Neonate or infant participating simultaneously in another interventional study.
  • Neonates or infants whose parents' situations may jeopardize the interpretation of the results.
  • Neonates or infants whose parents' refuse video recording, required to respond to the primary objective of the study.

Treatment and study plan

OT

Drug

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

Other names: oxytocin

placebo comparator

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Epidemiological and Clinical Research Information Network
  • International Clinical Trials Association

Registry information

Official study 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

Acronym: OTBB3

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 25, 2020
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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