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

Preterm Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04009655
• Other study ID #: MTOBF
• Status: Completed
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: May 2020
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigators aim to discover the effects of music therapy on near-infrared spectroscopy and electroencephalogram in premature infants.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 224 Days to 258 Days

Eligibility

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.

Related Conditions & MeSH terms

• Electroencephalogram
• Music
• Near-infrared Spectroscopy
• Premature Birth
• Preterm Infant

Intervention

Other:
• music
music selected by musician

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	change of heart rates	monitors recording heart rates	from the start of the intervention to the end of the 3rd day
Secondary	change of respiratory rates	monitors recording respiratory rates	from the start of the intervention to the end of the 3rd day
Secondary	change of pluse oxygen saturation	monitors recording transcutaneous oxygen saturation	from the start of the intervention to the end of the 3rd day