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

Not Applicable

Completed

• Conditions: Music; Preterm Infant; Near-infrared Spectroscopy; Electroencephalogram
• Interventions: Other: music

• Registration Number: NCT04009655
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Study Start: 2019-08-15
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
music therapy	music	The infant will receive music therapy over 3 consecutive days and will obtain standard care as usual

Primary Outcome Measures

Name	Time	Method
change of brain oxygen saturation	from the start of the intervention to the end of the 3rd day	near-infrared spectroscopy to monitor brain oxygen saturation

Secondary Outcome Measures

Name	Time	Method
change of respiratory rates	from the start of the intervention to the end of the 3rd day	monitors recording respiratory rates
Burdjalov Scores of amplitude integrated electroencephalogram	from the start of the intervention to the end of the 3rd day	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	from the start of the intervention to the end of the 3rd day	monitors recording heart rates
change of pluse oxygen saturation	from the start of the intervention to the end of the 3rd day	monitors recording transcutaneous oxygen saturation

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China