Back to resultsThe Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants
Primary Purpose
Preterm Infants
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
music
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Infants focused on measuring metabolic rate, music, preterm infants, energy expenditure, NIDCA
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
Sites / Locations
- Department of Neonatology, Tel Aviv Medcil Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
music therapy
Arm Description
Each infant was randomized to receive music therapy or no music over 2 consecutive days
Outcomes
Primary Outcome Measures
Energy Expenditure (EE)
Secondary Outcome Measures
Full Information
NCT ID
NCT00838474
First Posted
February 5, 2009
Last Updated
February 5, 2009
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00838474
Brief Title
The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants
Official Title
The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants
Keywords
metabolic rate, music, preterm infants, energy expenditure, NIDCA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
music therapy
Arm Type
Other
Arm Description
Each infant was randomized to receive music therapy or no music over 2 consecutive days
Intervention Type
Other
Intervention Name(s)
music
Intervention Description
Each infant was randomized to receive music therapy or no music over 2 consecutive days
Primary Outcome Measure Information:
Title
Energy Expenditure (EE)
Time Frame
during measurment of EE
10. Eligibility
Sex
All
Maximum Age & Unit of Time
60 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Department of Neonatology, Tel Aviv Medcil Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
19969615
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants
We'll reach out to this number within 24 hrs