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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

February 5, 2009
February 5, 2009
October 2007
July 2008   (final data collection date for primary outcome measure)
Energy Expenditure (EE) [ Time Frame: during measurment of EE ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants
The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Preterm Infants
Other: music
Each infant was randomized to receive music therapy or no music over 2 consecutive days
music therapy
Each infant was randomized to receive music therapy or no music over 2 consecutive days
Intervention: Other: music
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.
 
Completed
20
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
up to 60 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00838474
07-346
No
Dror Mandel, MD, Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP