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Completed

NCT Number: NCT04009655

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

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.

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Key information

Conditions

Preterm Infant Electroencephalogram Female Urogenital Diseases and Pregnancy Complications Music Near-Infrared Spectroscopy Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

224 day–258 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music

Other

music selected by musician

Primary outcomes

  1. change of brain oxygen saturation

    Time frame: from the start of the intervention to the end of the 3rd day

    near-infrared spectroscopy to monitor brain oxygen saturation

Secondary outcomes

  1. Burdjalov Scores of amplitude integrated electroencephalogram

    Time frame: 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.

  2. change of heart rates

    Time frame: from the start of the intervention to the end of the 3rd day

    monitors recording heart rates

  3. change of respiratory rates

    Time frame: from the start of the intervention to the end of the 3rd day

    monitors recording respiratory rates

  4. change of pluse oxygen saturation

    Time frame: from the start of the intervention to the end of the 3rd day

    monitors recording transcutaneous oxygen saturation

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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