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(352) 733-0111

Intranasal Oxytocin

  • Status
    Accepting Candidates
  • Age
    1 Week - 6 Months
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The purpose of this study is to compare the change in suck and swallow competency from baseline to morning of day 6 with intranasal oxytocin spray vs placebo in infants/children with Prader-Willi Syndrome who are in nutritional phase 1a. Videofluoroscopic swallow studies will be performed on treatment day 1 and on the day following treatment morning of day 6.

Description

The overall objective of this Phase 2 trial is to compare the change from baseline to morning of day 6 of Internasal Oxytocin (IN-OT) on suck and swallow competency in infants/children with Prader-Willi Syndrome (PWS) who are in nutritional phase 1a.

Study Hypothesis 1: The Study team hypothesize that replacing Oxytocin (Ot) in infants and children who are in nutritional phase 1a will improve their suck and swallow, potentially even eliminating the need for gastrostomy tubes and nasogastric tubes for feeding, and decreasing the risk of aspiration with oral feeding.

Study Hypothesis 2: The Study team hypothesize that replacing Ot in infants and children with PWS will result in improved eye contact, daytime alertness, and feelings of bonding between the parents and the infant.

Details

Full study title Intranasal Oxytocin for Treatment of Infants and Children with Prader-Willi Syndrome in Nutritional Phase 1a
Protocol number OCR16237
ClinicalTrials.gov ID NCT03245762
Phase Phase 1/Phase 2

Eligibility

Inclusion Criteria:

  1. Individuals with genetically confirmed PWS who are in nutritional phase 1a, as determined by PI

  2. Physical exam and laboratory results that are within the normal range.

  3. Presence of a parent/caregiver/guardian that is able to consent for their participation.

Exclusion Criteria:

  1. Exposure to any investigational agent in the 30 days prior to randomization.

  2. Prior chronic treatment with oxytocin.

  3. A medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger the subject's well-being.

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.