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

May 3, 2015 updated by: The Baruch Padeh Medical Center, Poriya

Effects of Medical Clowning (Dream Doctors) on the Development of the Nervous System and the Relationship Between Preterm Premature Baby Parents and NICU Staff

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Tiberias, Israel, 15208
        • Recruiting
        • The Baruch Padeh Medical Center - Poria
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Shosh Ofir
        • Sub-Investigator:
          • Orly Benor, RN
        • Sub-Investigator:
          • Aminat Libay, MD
        • Principal Investigator:
          • Hagit Friedman, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Premature neonates 32 weeks gestation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Family-Based
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
premature neonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
◦Developmental assessment - a composite of several measures
Time Frame: ◦Time Frame: 3 month
◦Time Frame: 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Developmental assessment - a composite of several measures
Time Frame: ◦◦Time Frame: 18 month
Safety Issue?: No
◦◦Time Frame: 18 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Baruch Padeh Medical Center, Poriya

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 3, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38-2013.CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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