Bach Music in Preterm Infants: No "Mozart Effect" on Resting Energy Expenditure

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.

Study Overview

• Status: Completed
• Conditions: Resting Energy Expenditure
• Intervention / Treatment: Other: Mozart music; Other: Bach music

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Tel Aviv Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 days to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Preterm infants at post menstrual age of 30-37 weeks who were appropriate for gestational age, clinically and thermally stable, gavage-fed, were eligible for recruitment.
• At the time of the study they were all tolerating full enteral feeding (150-160 cc/kg weight/day) without significant gastric residuals (<5% of total feed), they were all growing steadily, and had no electrolyte imbalance.
• All infants who were recruited successfully passed a hearing screening test prior to discharge (otoacoustic emission and automated auditory brainstem response)

Exclusion Criteria:

• Infants with significant complications of prematurity such as intraventricular hemorrhage, periventricular leucomalacia, necrotizing enterocolitis, active apneas of prematurity, patent ductus arteriosus, active infection, electrolyte imbalance and major congenital anomalies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Music by Mozart; The sequence by which Bach, Mozart, or no music were administered (over 3 consecutive days) was determined by randomization using random numbers. Infants listened to Bach or Mozart using the compact discs entitled "Baby Bach" and "Baby Mozart" (Baby smart, Nir Zvi, Israel). The music was played using a music player at a volume of 65-70 dB with attached speakers which were placed at a distance of 30 cm from the infant's ears. According to the American Academy of Pediatrics recommendations (5): the volume did not exceed 75dB and the background noise near the infant's ears was maintained below 45 dB. Music (Mozart or Bach) was initiated 10 minutes prior to the beginning of the metabolic measurements and continued for 30 minutes while energy expenditure (EE) was recorded. In the same manner EE was recorded for each infant with no music therapy.	Other: Mozart music; Infants listened to Bach or Mozart using the compact discs entitled "Baby Bach" and "Baby Mozart" (Baby smart, Nir Zvi, Israel).
Active Comparator: Bach Music; The sequence by which Bach, Mozart, or no music were administered (over 3 consecutive days) was determined by randomization using random numbers. Infants listened to Bach or Mozart using the compact discs entitled "Baby Bach" and "Baby Mozart" (Baby smart, Nir Zvi, Israel). The music was played using a music player at a volume of 65-70 dB with attached speakers which were placed at a distance of 30 cm from the infant's ears. According to the American Academy of Pediatrics recommendations (5): the volume did not exceed 75dB and the background noise near the infant's ears was maintained below 45 dB. Music (Mozart or Bach) was initiated 10 minutes prior to the beginning of the metabolic measurements and continued for 30 minutes while energy expenditure (EE) was recorded. In the same manner EE was recorded for each infant with no music therapy.	Other: Bach music; Infants listened to Bach or Mozart using the compact discs entitled "Baby Bach" and "Baby Mozart" (Baby smart, Nir Zvi, Israel).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting energy expenditure	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.	3 CONSECUTIVE DAYS

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Dror Mandel, MD, Direcrotr, NICU

Publications and helpful links

General 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. doi: 10.1542/peds.2009-0990. Epub 2009 Dec 7.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: May 8, 2012
• First Submitted That Met QC Criteria: May 8, 2012
• First Posted (Estimate): May 9, 2012

Study Record Updates

• Last Update Posted (Estimate): May 9, 2012
• Last Update Submitted That Met QC Criteria: May 8, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 07-346 TLV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No