← Back to Search

Music therapy for Preterm Infants (NICU-MT Trial)

N/A
Waitlist Available
Led By Jayalakshmi Bodani
Research Sponsored by Saskatchewan Health Authority - Regina Area
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 - 24 months
Awards & highlights

NICU-MT Trial Summary

Several positive physiological and behavioural outcomes have been observed in preterm infants exposed to music therapy during their stay at Neonatal Intensive Care Units (NICU). There is ample evidence in the literature showing that brief exposure to music can lead to superior performance on a host of cognitive tasks in laboratory settings in children, adolescent and adults. However, till date no study has examined the cognitive benefits of NICU music therapy in preterm infants. Further habituation tests have been employed to examine cognitive functioning in infants in laboratory setting but the same test have not been employed as a measure to examine early cognitive functioning in preterm infants. This project will be carried out to examine the benefits of NICU music therapy on the cognitive functioning of preterm infants born at 27- 33 weeks of gestational age. A randomized controlled research design will be employed to compare cognitive functioning between the treatment and control group at 18 - 24 months of corrected gestational age. The treatment group will be exposed to music therapy during their stay in NICU and the controlled group will be exposed to all standardized care available at our institution except music therapy. Habituation tests will be used to examine cognitive functioning of the preterm infants in groups at 18 - 24 months of gestational age.

Eligible Conditions
  • Preterm Infants

NICU-MT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 - 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 - 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time looking at a familiar stimulus
Secondary outcome measures
Behavioral measure
Physiological measure
Other outcome measures
Other outcome
Other outcomes

NICU-MT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Music therapyExperimental Treatment1 Intervention
After the initial warm up session music therapy will be delivered three times a week for 15-20 minutes. All babies in the experimental group will be exposed to three weeks of music therapy sessions that is a total of 9 music therapy session prior to discharge from the hospital. The baby will be placed at the bassinet 15 minutes before music therapy begins. The baby will be in the bassinet during music therapy and 15 minutes post music therapy to allow measurement of physiological indicators. If parents are present during music therapy they will not engage in kangaroo care during the music therapy session or when physiological measurements are being taken pre and post music therapy, but can do so at other times.
Group II: ControlActive Control1 Intervention
Infants in this group will not receive any music therapy but will receive all other standard care provided to infants at the Regina General Hospital (RGH). All measurements will be carried out for all the infants in this group at the time when observations are carried out for infants in the music therapy group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Music therapy
2016
Completed Phase 4
~1220

Find a Location

Who is running the clinical trial?

Saskatchewan Health Authority - Regina AreaLead Sponsor
27 Previous Clinical Trials
5,416 Total Patients Enrolled
University of ReginaOTHER
48 Previous Clinical Trials
8,414 Total Patients Enrolled
Jayalakshmi BodaniPrincipal InvestigatorSaskatchewan Health Authority - Regina Area

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~11 spots leftby Apr 2025