The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants

Conditions
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Preterm Infant, Music, Near-infrared Spectroscopy, Electroencephalogram

Intervention / Treatment
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* Other: music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Have nervous system diseases or obvious nervous system symptoms. Severe congenital diseases. The maintenance of sedative or analgesic drugs. Support with mechanical ventilation.

Ages Eligible for Study
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Minimum Age: 224 Days
Maximum Age: 258 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: music therapy<br>The infant will receive music therapy over 3 consecutive days and will obtain standard care as usual | Other: music<br>* music selected by musician<br>|
| No Intervention: control<br>The infant does not receive any sound emission because the headphone will be turned off and will obtain standard care as experimental | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of brain oxygen saturation | near-infrared spectroscopy to monitor brain oxygen saturation | from the start of the intervention to the end of the 3rd day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from the start of the intervention to the end of the 3rd day | 
| change of heart rates | monitors recording heart rates | from the start of the intervention to the end of the 3rd day | 
| change of respiratory rates | monitors recording respiratory rates | from the start of the intervention to the end of the 3rd day | 
| change of pluse oxygen saturation | monitors recording transcutaneous oxygen saturation | from the start of the intervention to the end of the 3rd day |