ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00838474
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : February 6, 2009
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Preterm Infants Other: music Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants
Study Start Date : October 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Energy Expenditure (EE) [ Time Frame: during measurment of EE ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 60 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838474


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

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
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications