The Effect of Music by Mozart on Energy Expenditure in Gr... | NCT00838474

Studies
The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants

NCT00838474

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Completed

Last Update Posted

Feb 6, 2009Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Preterm Infants

Interventions

music

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Feb 5, 2009

First Submission Date that Met QC Criteria

Feb 5, 2009

First Posted Date

Feb 6, 2009Estimated

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

Feb 5, 2009

Last Update Posted Date

Feb 6, 2009Estimated

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

Music has been consistently shown to reduce stress and increase weight gain in premature infants. The mechanism of this presumed improved metabolic efficiency is unknown. We aim to test the hypothesis that music by Mozart reduces energy expenditure in growing healthy preterm infants.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
music therapy	Other	Each infant was randomized to receive music therapy or no music over 2 consecutive days	Other: music

Interventions

Name	Type	Description	Arm Group Labels	Other Names
music	Other	Each infant was randomized to receive music therapy or no music over 2 consecutive days	music therapy

Measure	Description	Time Frame
Energy Expenditure (EE)		during measurment of EE

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

appropriate weight for gestational age
postmenstrual age of 30-37 weeks
gavage fed
tolerating full enteral feedings without significant gastric residuals (>5% of total feed)
no electrolyte imbalance

Exclusion Criteria:

congenital anomalies
dysmorphism
intracranial hemorrhage of any grade
periventricular leukomalacia
necrotizing enterocolitis
supplemental oxygen requirements by 28 days of age or by 36 weeks of postmenstrual age and at least 1 week prior to measurement
active infection
patent ductus arteriosus
apnea of prematurity

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

60 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neonatology, Tel Aviv Medcil Center		Tel Aviv		64239	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19969615	Derived	Lubetzky R, Mimouni FB, Dollberg S, Reifen R, Ashbel G, Mandel D. Effect of music by Mozart on energy expenditure in growing preterm infants. Pediatrics. 2010 Jan;125(1):e24-8. doi: 10.1542/peds.2009-0990. Epub 2009 Dec 7.

ID	Term
D026421	Sensory Art Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D012046	Rehabilitation