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

Not Applicable

Completed

• Conditions: Resting Energy Expenditure
• Interventions: Other: Mozart music; Other: Bach music

• Registration Number: NCT01595191
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-05
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-08
• Last Update Submitted: 2012-05-08
• Study First Posted: 2012-05-09
• Last Update Posted: 2012-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Music by Mozart	Mozart 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.
Bach Music	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.

Primary Outcome Measures

Name	Time	Method
Resting energy expenditure	3 CONSECUTIVE DAYS	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.

Trial Locations

Locations (1)

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel