NCT00838474

Brief Summary

Music has been consistently shown to reduce stress and increase weight gain in premature infants. The mechanism of this presumed improved metabolic efficiency is unknown. We aim to test the hypothesis that music by Mozart reduces energy expenditure in growing healthy preterm infants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

9 months

First QC Date

February 5, 2009

Last Update Submit

February 5, 2009

Conditions

Preterm Infants

Keywords

metabolic ratemusicpreterm infantsenergy expenditureNIDCA

Outcome Measures

Primary Outcomes (1)

  • Energy Expenditure (EE)

    during measurment of EE

Study Arms (1)

music therapy

OTHER

Each infant was randomized to receive music therapy or no music over 2 consecutive days

Other: music

Interventions

musicOTHER

Each infant was randomized to receive music therapy or no music over 2 consecutive days

music therapy

Eligibility Criteria

AgeUp to 60 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • appropriate weight for gestational age
  • postmenstrual age of 30-37 weeks
  • gavage fed
  • tolerating full enteral feedings without significant gastric residuals (\>5% of total feed)
  • no electrolyte imbalance

You may not qualify if:

  • congenital anomalies
  • dysmorphism
  • intracranial hemorrhage of any grade
  • periventricular leukomalacia
  • necrotizing enterocolitis
  • supplemental oxygen requirements by 28 days of age or by 36 weeks of postmenstrual age and at least 1 week prior to measurement
  • active infection
  • patent ductus arteriosus
  • apnea of prematurity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neonatology, Tel Aviv Medcil Center

Tel Aviv, 64239, Israel

Location

Related 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.

    PMID: 19969615DERIVED

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 6, 2009

Study Start

October 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations

IL(1)