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

Preterm Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838474
• Other study ID #: 07-346
• Status: Completed
• Phase: N/A
• First received: February 5, 2009
• Last updated: February 5, 2009
• Start date: October 2007
• Est. completion date: July 2008

Study information

• Verified date: February 2009
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 60 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants

Intervention

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

Locations

Country	Name	City	State
Israel	Department of Neonatology, Tel Aviv Medcil Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy Expenditure (EE)		during measurment of EE	No