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

NCT ID: NCT00838474

Last Updated: 2009-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Preterm Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Study Groups

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music therapy

Each infant was randomized to receive music therapy or no music over 2 consecutive days

Group Type OTHER

music

Intervention Type OTHER

Each infant was randomized to receive music therapy or no music over 2 consecutive days

Interventions

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music

Each infant was randomized to receive music therapy or no music over 2 consecutive days

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

60 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tel-Aviv Sourasky Medical Center

Locations

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Department of Neonatology, Tel Aviv Medcil Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 19969615 (View on PubMed)

Other Identifiers

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07-346

Identifier Type: -

Identifier Source: org_study_id

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