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Cognitive Processing in Preterm Infants and NICU Music Therapy

NCT04314440 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2020-03-19

No results posted yet for this study

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.

Conditions

  • Other Preterm Infants

Interventions

BEHAVIORAL

Music therapy

An accredited music therapist will deliver 15-20 minutes of music therapy every day, 4-5 days in week one and remaining in week two to all MT participants. All participants in music therapy group will get a total of nine sessions. The lullaby "twinkle twinkle little star" will be sung for \~5 minutes, followed by the same songs played on acoustic guitar for \~5 minutes and another \~5 minutes of the same song sung in voice. This protocol will be followed in all 9 sessions for all infants in the experimental arm. The sound levels will be maintained at 55-65 decibels (dB) using appropriate meters. If MT is interrupted within 10 minutes then a make-up session will be delivered, assuming no discharge. In case of missed sessions and interrupted session infants will receive a maximum of 12 session.

Sponsors & Collaborators

  • University of Regina

    collaborator OTHER

  • Saskatchewan Health Authority - Regina Area

    lead OTHER

Principal Investigators

  • Jayalakshmi Bodani · Saskatchewan Health Authority - Regina Area

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
27 Weeks
Max Age
33 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04314440 on ClinicalTrials.gov