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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01595191
Other study ID # 07-346 TLV
Secondary ID
Status Completed
Phase N/A
First received May 8, 2012
Last updated May 8, 2012
Start date July 2010
Est. completion date December 2010

Study information

Verified date May 2012
Source Tel-Aviv Sourasky Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 59 Days
Eligibility 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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Bach music
Infants listened to Bach or Mozart using the compact discs entitled "Baby Bach" and "Baby Mozart" (Baby smart, Nir Zvi, Israel).
Mozart music
Infants listened to Bach or Mozart using the compact discs entitled "Baby Bach" and "Baby Mozart" (Baby smart, Nir Zvi, Israel).

Locations

Country Name City State
Israel Tel Aviv Medical Center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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