Medical Clowning in the NICU (Neonatal Intensive Care Uni... | NCT02048202

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

NCT02048202

Sponsor

The Baruch Padeh Medical Center, Poriya

Status

Unknown status

Last Update Posted

May 5, 2015Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Premature Neonate

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2016Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Jan 21, 2014

First Submission Date that Met QC Criteria

Jan 27, 2014

First Posted Date

Jan 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2015

Last Update Posted Date

May 5, 2015Estimated

Name	Class
University of Haifa	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Label	Type	Description	Intervention Names
premature neonate		premature neonate

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

4 Weeks

Standard Ages

Child

Study Population

Premature neonates 32 weeks gestation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shay Barak, MD	Contact	050-6267496		sbarak@poria.health.gov.il
Hagit Friedman, PhD	Contact	050-6267427		hmts@netvision.net.il

Overall Officials

Name	Affiliation	Role
Shay Barak, MD	The Baruch Padeh Medical Center - Poria	Principal Investigator
Amir Kushnir, MD	The Baruch Padeh Medical Center - Poria	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Baruch Padeh Medical Center - Poria	Recruiting	Tiberias		15208	Israel

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided