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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04009655
Enrollment
45
Registered
2019-07-05
Start date
2019-08-15
Completion date
2019-12-15
Last updated
2020-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electroencephalogram, Music, Near-infrared Spectroscopy, Preterm Infant

Brief 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. 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.

Interventions

OTHERmusic

music selected by musician

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
224 Days to 258 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
change of brain oxygen saturationfrom the start of the intervention to the end of the 3rd daynear-infrared spectroscopy to monitor brain oxygen saturation

Secondary

MeasureTime frameDescription
Burdjalov Scores of amplitude integrated electroencephalogramfrom the start of the intervention to the end of the 3rd dayelectroencephalogram 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.
change of heart ratesfrom the start of the intervention to the end of the 3rd daymonitors recording heart rates
change of respiratory ratesfrom the start of the intervention to the end of the 3rd daymonitors recording respiratory rates
change of pluse oxygen saturationfrom the start of the intervention to the end of the 3rd daymonitors recording transcutaneous oxygen saturation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026