Back to resultsThe Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants
Primary Purpose
Preterm Infant, Music, Near-infrared Spectroscopy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
music
Sponsored by
About this trial
This is an interventional supportive care trial for Preterm Infant
Eligibility Criteria
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.
Sites / Locations
- Children's Hospital of Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
music therapy
control
Arm Description
The infant will receive music therapy over 3 consecutive days and will obtain standard care as usual
The infant does not receive any sound emission because the headphone will be turned off and will obtain standard care as experimental
Outcomes
Primary Outcome Measures
change of brain oxygen saturation
near-infrared spectroscopy to monitor brain oxygen saturation
Secondary Outcome Measures
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.
change of heart rates
monitors recording heart rates
change of respiratory rates
monitors recording respiratory rates
change of pluse oxygen saturation
monitors recording transcutaneous oxygen saturation
Full Information
NCT ID
NCT04009655
First Posted
May 31, 2019
Last Updated
May 7, 2020
Sponsor
Children's Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT04009655
Brief Title
The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants
Official Title
The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Music, Near-infrared Spectroscopy, Electroencephalogram
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
music therapy
Arm Type
Experimental
Arm Description
The infant will receive music therapy over 3 consecutive days and will obtain standard care as usual
Arm Title
control
Arm Type
No Intervention
Arm Description
The infant does not receive any sound emission because the headphone will be turned off and will obtain standard care as experimental
Intervention Type
Other
Intervention Name(s)
music
Intervention Description
music selected by musician
Primary Outcome Measure Information:
Title
change of brain oxygen saturation
Description
near-infrared spectroscopy to monitor brain oxygen saturation
Time Frame
from the start of the intervention to the end of the 3rd day
Secondary Outcome Measure Information:
Title
Burdjalov Scores of amplitude integrated electroencephalogram
Description
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.
Time Frame
from the start of the intervention to the end of the 3rd day
Title
change of heart rates
Description
monitors recording heart rates
Time Frame
from the start of the intervention to the end of the 3rd day
Title
change of respiratory rates
Description
monitors recording respiratory rates
Time Frame
from the start of the intervention to the end of the 3rd day
Title
change of pluse oxygen saturation
Description
monitors recording transcutaneous oxygen saturation
Time Frame
from the start of the intervention to the end of the 3rd day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
224 Days
Maximum Age & Unit of Time
258 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lai s wang, Ph.D
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants
We'll reach out to this number within 24 hrs