The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedStudy Start
First participant enrolled
August 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2019
CompletedMay 11, 2020
May 1, 2020
4 months
May 31, 2019
May 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Burdjalov Scores of amplitude integrated electroencephalogram
from the start of the intervention to the end of the 3rd day
change of heart rates
from the start of the intervention to the end of the 3rd day
change of respiratory rates
from the start of the intervention to the end of the 3rd day
change of pluse oxygen saturation
from the start of the intervention to the end of the 3rd day
Study Arms (2)
music therapy
EXPERIMENTALThe infant will receive music therapy over 3 consecutive days and will obtain standard care as usual
control
NO INTERVENTIONThe infant does not receive any sound emission because the headphone will be turned off and will obtain standard care as experimental
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Have nervous system diseases or obvious nervous system symptoms.
- Severe congenital diseases.
- The maintenance of sedative or analgesic drugs.
- Support with mechanical ventilation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
lai s wang, Ph.D
Children's Hospital of Fudan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2019
First Posted
July 5, 2019
Study Start
August 15, 2019
Primary Completion
December 15, 2019
Study Completion
December 15, 2019
Last Updated
May 11, 2020
Record last verified: 2020-05