Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

music

Other
Who is being recruted

Urogenital Diseases+3

+ Female Urogenital Diseases and Pregnancy Complications

+ Obstetric Labor Complications

+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: August 2019
See protocol details

Summary

Principal SponsorChildren's Hospital of Fudan University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 15, 2019

Actual date on which the first participant was enrolled.

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.

Official TitleThe Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants
NCT04009655
Principal SponsorChildren's Hospital of Fudan University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsObstetric Labor ComplicationsObstetric Labor, PrematurePregnancy ComplicationsPremature Birth

Criteria

4 inclusion criteria required to participate
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.
4 exclusion criteria prevent from participating
Have nervous system diseases or obvious nervous system symptoms.
Severe congenital diseases.
The maintenance of sedative or analgesic drugs.
Support with mechanical ventilation.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Children's Hospital of Fudan University

Shanghai, ChinaOpen Children's Hospital of Fudan University in Google Maps
CompletedOne Study Center