Preterm InfantNCT04009655
The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants
A study testing music in people with Preterm Infant and Music, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Music has been consistently shown magic power in brain plasticity. Several study proved music can influence electronic activity of preterm infants' brain, while none study covered region oxygen metabolic. Read more about this study
- Who is it for?
- Ages 224 to 258 days
- Conditions the study is for
- Preterm Infant, Music, Near-infrared Spectroscopy
- What is being tested?
- music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2019to 15 Dec 2019
- 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 224 to 258 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Postmenstrual age of 32-36+6 weeks.
- Appropriate weight for gestational age.
- To have signed an informed consent to participate in the study.
- Have reached clinical stability.
Who cannot join
- Have nervous system diseases or obvious nervous system symptoms.
- Severe congenital diseases.
- The maintenance of sedative or analgesic drugs.
- Support with mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Music has been consistently shown magic power in brain plasticity. Several study proved music can influence electronic activity of preterm infants' brain, while none study covered region oxygen metabolic. The investigators aim to discover the effects of music therapy on near-infrared spectroscopy and electroencephalogram in premature infants.
Read the detailed description
Previous studies of music therapy have made some achievements for adult Parkinson's disease, schizophrenia, depression, anxiety, post-traumatic stress and pediatric autism spectrum disorders. For newborns, studies mainly focused on the effects of basic vital signs, feeding and pain score decreasing. So far, no studies evaluating the effect of music therapy on brain oxygen metabolic and electronic activity.
- Being tested
- music
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
music selected by musician
| Study group | Role | What they receive |
|---|---|---|
| music therapy | Experimental | The infant will receive music therapy over 3 consecutive days and will obtain standard care as usual Receives: Other: music |
| control | No intervention | The infant does not receive any sound emission because the headphone will be turned off and will obtain standard care as experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of brain oxygen saturation
near-infrared spectroscopy to monitor brain oxygen saturation
Measured: from the start of the intervention to the end of the 3rd day
Secondary outcomes (4)
Burdjalov Scores of amplitude integrated electroencephalogram
electroencephalogram to monitor brain electronic activity, using Burdjalov developed cerebral function monitoring scoring system which including: (1)record continuity: assessed through observing the overall density of the sample tracing, scores ranged from 0 to 2；(2) presence of cyclic changes：refers to the emergence and progression of periods during monitoring，scores ranged from 0 to 5；（3）degree of voltage amplitude depression：estimated as the average lower microvolt level during the recording epoch ，scores ranged from 0 to 2；（4）bandwidth：reflects a combination of the voltage span (peak-to-trough) of the tracing and the magnitude of the electroencephalogram depression，scores ranged from 0 to 4. The minimum possible total score was 0, and the maximum was 13. Scores progressively increased with central nerve system maturation.
Measured: from the start of the intervention to the end of the 3rd day
change of heart rates
monitors recording heart rates
Measured: from the start of the intervention to the end of the 3rd day
change of respiratory rates
monitors recording respiratory rates
Measured: from the start of the intervention to the end of the 3rd day
change of pluse oxygen saturation
monitors recording transcutaneous oxygen saturation
Measured: from the start of the intervention to the end of the 3rd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start15 Aug 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- lai s wang, Ph.D, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009655
- Sponsor's protocol ID
- MTOBF
- Status last verified
- May 2020
- First submitted
- 31 May 2019
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants
- ClinicalTrials.gov ID
- NCT04009655
- Acronym / sponsor ID
- MTOBF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 5 Jul 2019 (actual)
- 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 magic power in brain plasticity. Several study proved music can influence electronic activity of preterm infants' brain, while none study covered region oxygen metabolic. The investigators aim to discover the effects of music therapy on near-infrared spectroscopy and electroencephalogram in premature infants.
Detailed description
Previous studies of music therapy have made some achievements for adult Parkinson's disease, schizophrenia, depression, anxiety, post-traumatic stress and pediatric autism spectrum disorders. For newborns, studies mainly focused on the effects of basic vital signs, feeding and pain score decreasing. So far, no studies evaluating the effect of music therapy on brain oxygen metabolic and electronic activity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music therapy | Experimental | Other: musicThe infant will receive music therapy over 3 consecutive days and will obtain standard care as usual |
| control | No intervention | –The infant does not receive any sound emission because the headphone will be turned off and will obtain standard care as experimental |
Who may qualify
- Ages
- 224 to 258 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Postmenstrual age of 32-36+6 weeks.
- Appropriate weight for gestational age.
- To have signed an informed consent to participate in the study.
- Have reached clinical stability.
Key exclusion criteria (4 listed)
- Have nervous system diseases or obvious nervous system symptoms.
- Severe congenital diseases.
- The maintenance of sedative or analgesic drugs.
- Support with mechanical ventilation.
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 |
|---|---|---|
| musicmusic selected by musician | Other | music therapy |
Primary outcome
change of brain oxygen saturation
Time frame: from the start of the intervention to the end of the 3rd day
near-infrared spectroscopy to monitor brain oxygen saturation
4 secondary outcomes
Burdjalov Scores of amplitude integrated electroencephalogram
Time frame: from the start of the intervention to the end of the 3rd day
change of heart rates
Time frame: from the start of the intervention to the end of the 3rd day
change of respiratory rates
Time frame: from the start of the intervention to the end of the 3rd day
change of pluse oxygen saturation
Time frame: from the start of the intervention to the end of the 3rd day
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 11 May 2020.
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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.
lai s wang, Ph.D study director
Children's Hospital of Fudan University
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 Infant and Music, run by Children's Hospital of Fudan University at 1 site in China.
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 4 inclusion and 4 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 11 May 2020. 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 China. 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?
change of brain oxygen saturation (time frame: from the start of the intervention to the end of the 3rd day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2020.