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

NCT ID: NCT02048202

Last Updated: 2015-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Premature Neonate

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

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premature neonate

premature neonate

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Haifa

OTHER

Sponsor Role collaborator

The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shay Barak, MD

Role: PRINCIPAL_INVESTIGATOR

The Baruch Padeh Medical Center - Poria

Amir Kushnir, MD

Role: STUDY_CHAIR

The Baruch Padeh Medical Center - Poria

Hagit Friedman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Haifa

Locations

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The Baruch Padeh Medical Center - Poria

Tiberias, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Shay Barak, MD

Role: CONTACT

050-6267496

Hagit Friedman, PhD

Role: CONTACT

050-6267427

Facility Contacts

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Shay Barak, MD

Role: primary

050-6267496

Hagit Friedman, PhD

Role: backup

050-5841317

Other Identifiers

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38-2013.CTIL

Identifier Type: -

Identifier Source: org_study_id

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