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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
  Purpose

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.


Condition Intervention
Preterm Infants
Other: music

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Energy Expenditure (EE) [ Time Frame: during measurment of EE ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
music therapy
Each infant was randomized to receive music therapy or no music over 2 consecutive days
Other: music
Each infant was randomized to receive music therapy or no music over 2 consecutive days

  Eligibility

Ages Eligible for Study:   up to 60 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838474

Locations
Israel
Department of Neonatology, Tel Aviv Medcil Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

No publications provided by Tel-Aviv Sourasky Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dror Mandel, MD, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00838474     History of Changes
Other Study ID Numbers: 07-346
Study First Received: February 5, 2009
Last Updated: February 5, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
metabolic rate
music
preterm infants
energy expenditure
NIDCA

ClinicalTrials.gov processed this record on November 20, 2014