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

• Conditions: Premature Neonate

• Registration Number: NCT02048202
• Lead Sponsor: The Baruch Padeh Medical Center, Poriya

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.

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-29
• Status Verified: 2015-01
• Last Update Submitted: 2015-05-03
• Last Update Posted: 2015-05-05
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
◦Developmental assessment - a composite of several measures	◦Time Frame: 3 month

Secondary Outcome Measures

Name	Time	Method
Developmental assessment - a composite of several measures	◦◦Time Frame: 18 month	Safety Issue?: No

Trial Locations

Locations (1)

The Baruch Padeh Medical Center - Poria; 🇮🇱 Tiberias, Israel