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临床试验/NCT01595191
NCT01595191已完成不适用

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

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2010年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Resting energy expenditure

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Days 至 59 Days(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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)

排除标准

  • •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.

研究组 & 干预措施

Music by Mozart

Active Comparator

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.

干预措施: Mozart music (Other)

Bach Music

Active Comparator

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.

干预措施: Bach music (Other)

结局指标

主要结局

Resting energy expenditure

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Michal Roll PhD,MBA

Head, Research institute

Tel-Aviv Sourasky Medical Center

研究点 (1)

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