- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00838474
The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants
February 5, 2009 updated by: Tel-Aviv Sourasky Medical Center
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Tel Aviv, Israel, 64239
- Department of Neonatology, Tel Aviv Medcil Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 month (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: music therapy
Each infant was randomized to receive music therapy or no music over 2 consecutive days
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Each infant was randomized to receive music therapy or no music over 2 consecutive days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Energy Expenditure (EE)
Time Frame: during measurment of EE
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during measurment of EE
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
February 5, 2009
First Submitted That Met QC Criteria
February 5, 2009
First Posted (Estimate)
February 6, 2009
Study Record Updates
Last Update Posted (Estimate)
February 6, 2009
Last Update Submitted That Met QC Criteria
February 5, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-346
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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