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

This study has been completed.
Sponsor:
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

May 8, 2012
May 8, 2012
July 2010
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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Bach Music in Preterm Infants: No "Mozart Effect" on Resting Energy Expenditure
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Resting Energy Expenditure
  • Other: Bach music
    Infants listened to Bach or Mozart using the compact discs entitled "Baby Bach" and "Baby Mozart" (Baby smart, Nir Zvi, Israel).
  • 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: 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.
    Intervention: Other: Mozart music
  • 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.
    Intervention: Other: Bach music
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
up to 59 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01595191
07-346 TLV
No
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Principal Investigator: Dror Mandel, MD Direcrotr, NICU
Tel-Aviv Sourasky Medical Center
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP