Bach Music in Preterm Infants: No "Mozart Effect" on Resting Energy Expenditure
This study has been completed.
Sponsor:
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01595191
First received: May 8, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | May 8, 2012 | ||||
| Last Updated Date | May 8, 2012 | ||||
| Start Date ICMJE | July 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Resting energy expenditure [ Time Frame: 3 CONSECUTIVE DAYS ] [ Designated as safety issue: No ] Metabolic measurements were performed by indirect calorimetry using the Deltatrac II Metabolic monitor (DateOhmeda, Helsinki, Finland). This system consists of a hood, which is placed over the infant's head and of two sensors. It uses the principle of an open circuit which allows for continuous measurements of O2 consumption and C02 production. The energy expenditure is calculated using the equation 5.5VO2+1.76VCO2. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bach Music in Preterm Infants: No "Mozart Effect" on Resting Energy Expenditure | ||||
| Official Title ICMJE | Bach Music in Preterm Infants: No "Mozart Effect" on Resting Energy Expenditure | ||||
| Brief Summary | Exposure to Mozart music significantly lowers resting energy expenditure (REE) in healthy preterm infants. Whether this finding is related to music per-se or to music by Mozart is unknown. The objective is to study whether J.S. Bach music has a lowering effect on REE similar to that of Mozart music. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Resting Energy Expenditure | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 12 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 59 Days | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01595191 | ||||
| Other Study ID Numbers ICMJE | 07-346 TLV | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center | ||||
| Study Sponsor ICMJE | Tel-Aviv Sourasky Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Tel-Aviv Sourasky Medical Center | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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