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

This study has been completed.

Sponsor:

Information provided by:

Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT00838474

First received: February 5, 2009

Last updated: NA

Last verified: February 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	February 5, 2009
Last Updated Date	February 5, 2009
Start Date ^ICMJE	October 2007
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 5, 2009)	Energy Expenditure (EE) [ Time Frame: during measurment of EE ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants
Official Title ^ICMJE	The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants
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
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Primary Purpose: Treatment
Condition ^ICMJE	Preterm Infants
Intervention ^ICMJE	Other: music Each infant was randomized to receive music therapy or no music over 2 consecutive days
Study Arm (s)	music therapy Each infant was randomized to receive music therapy or no music over 2 consecutive days Intervention: Other: music
Publications *	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. Epub 2009 Dec 7.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	July 2008
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	up to 60 Days
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00838474
Other Study ID Numbers ^ICMJE	07-346
Has Data Monitoring Committee	No
Responsible Party	Dror Mandel, MD, Tel-Aviv Sourasky Medical Center
Study Sponsor ^ICMJE	Tel-Aviv Sourasky Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Tel-Aviv Sourasky Medical Center
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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