Preterm InfantsNCT00838474
The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants
A study testing music in people with Preterm Infants, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 60 daysHealthy volunteers can take part
- Conditions the study is for
- Preterm Infants
- What is being tested?
- music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2007to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- active infection
- patent ductus arteriosus
- apnea of prematurity
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Preterm Infants
- Being tested
- music
- Keywords
- metabolic rate, music, preterm infants, energy expenditure, NIDCA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
Each infant was randomized to receive music therapy or no music over 2 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| music therapy | Other | Each infant was randomized to receive music therapy or no music over 2 consecutive days Receives: Other: music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy Expenditure (EE)
Measured: during measurment of EE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startOct 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838474
- Sponsor's protocol ID
- 07-346
- Status last verified
- Feb 2009
- First submitted
- 5 Feb 2009
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19969615
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants
- ClinicalTrials.gov ID
- NCT00838474
- Acronym / sponsor ID
- 07-346
- Conditions
- Preterm Infants
- Keywords
- metabolic rate, music, preterm infants, energy expenditure, NIDCA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| music therapy | Other | Other: musicEach infant was randomized to receive music therapy or no music over 2 consecutive days |
Who may qualify
- Ages
- Up to 60 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- congenital anomalies
- dysmorphism
- intracranial hemorrhage of any grade
- periventricular leukomalacia
- necrotizing enterocolitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| musicEach infant was randomized to receive music therapy or no music over 2 consecutive days | Other | music therapy |
Primary outcome
Energy Expenditure (EE)
Time frame: during measurment of EE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2009.
- Derived from this study: PubMed 19969615Lubetzky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music in people with Preterm Infants, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Expenditure (EE) (time frame: during measurment of EE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00838474, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2009.