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

Premature Neonate Clinical Trial

— clowns  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02048202
• Other study ID #: 38-2013.CTIL
• Status: Recruiting
• Phase: N/A
• First received: January 21, 2014
• Last updated: May 3, 2015
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2015
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: Shay Barak, MD
• Phone: 050-6267496
• Email: sbarak[@]poria.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Weeks

Eligibility

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 Design

Observational Model: Family-Based, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth
• Premature Neonate

Locations

Country	Name	City	State
Israel	The Baruch Padeh Medical Center - Poria	Tiberias

Sponsors (2)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya	University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	?Developmental assessment - a composite of several measures		?Time Frame: 3 month	No
Secondary	Developmental assessment - a composite of several measures	Safety Issue?: No	??Time Frame: 18 month	No