Clincosm LogoSign in Get a demo

clowns: Medical Clowning in the NICU (Neonatal Intensive Care Unit and Their Effects on Parents and Staff

Sponsor
The Baruch Padeh Medical Center, Poriya (Other)
Overall Status
Unknown status
CT.gov ID
NCT02048202
Collaborator
University of Haifa (Other)
60
Enrollment
1
Location
24
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will compare intervention by Infant Aquatics to infant massage. The intervention in both methods will start at 36 weeks gestational age for 3 months and will consist of sessions with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18 months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive behavior scales.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Preterm infants, a continuously growing population, are at high risk for neurodevelopment impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly due to developmental brain injury. Infant Aquatics have been found to benefit and promote infant development. The support and sensory stimulation of the water may improve the development the sensory, motor, as well as, autonomic system of preterm infants.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Family-Based
    Time Perspective:
    Prospective
    Official Title:
    Effects of Medical Clowning (Dream Doctors) on the Development of the Nervous System and the Relationship Between Preterm Premature Baby Parents and NICU Staff
    Study Start Date :
    Jan 1, 2014
    Anticipated Primary Completion Date :
    Jan 1, 2016
    Anticipated Study Completion Date :
    Jan 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    premature neonate

    premature neonate

    Outcome Measures

    Primary Outcome Measures

    1. ◦Developmental assessment - a composite of several measures [◦Time Frame: 3 month]

    Secondary Outcome Measures

    1. Developmental assessment - a composite of several measures [◦◦Time Frame: 18 month]

      Safety Issue?: No

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 4 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • neonates wherein their parents have expressed consent to participate in trail

    • neonates with parents who are able to understand and fill in questioners

    • neonates with no chromosomal deficiencies and no genetic deficiency

    Exclusion Criteria:

    • neonates with parents who are unable to understand and fill in questioners

    • neonates with intraventricular bleeding IVH/PVH

    • neonates with periventricular hemorrhage

    • neonates with known chromosomal deficiencies or genetic deficiency

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Baruch Padeh Medical Center - Poria Tiberias Israel 15208

    Sponsors and Collaborators

    • The Baruch Padeh Medical Center, Poriya
    • University of Haifa

    Investigators

    • Principal Investigator: Shay Barak, MD, The Baruch Padeh Medical Center - Poria
    • Study Chair: Amir Kushnir, MD, The Baruch Padeh Medical Center - Poria
    • Principal Investigator: Hagit Friedman, PhD, University of Haifa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Baruch Padeh Medical Center, Poriya
    ClinicalTrials.gov Identifier:
    NCT02048202
    Other Study ID Numbers:
    • 38-2013.CTIL
    First Posted:
    Jan 29, 2014
    Last Update Posted:
    May 5, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by The Baruch Padeh Medical Center, Poriya
    clown
    neonate
    premature
    Additional relevant MeSH terms:
    Premature Birth

    Study Results

    No Results Posted as of May 5, 2015