Cognitive Processing in Preterm Infants and NICU Music Therapy

NCT04314440 | Unknown

• 1 other identifier: REB15-100
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cognitive; Preterm; Infants; Music; Therapy; NICU

Outcome Measures

Primary Outcomes (1)

• Time looking at a familiar stimulus

  Average difference in rate of habituation as measure by the time looking at a familiar stimulus in mili-seconds between experimental and control groups.

  18 - 24 months

Secondary Outcomes (7)

• Physiological measure

  15 minutes,before, during, after music therapy, 6 days a week

• Physiological measure

  15 minutes,before, during, after music therapy, 6 days a week

• Physiological measure

  15 minutes,before, during, after music therapy, 6 days a week

• Behavioral measure

  Before to after music therapy 6 days a week

• Behavioral measure

  Before to after music therapy 6 days a week

Other Outcomes (4)

• Other outcomes

  Baseline to 3 weeks when music therapy is complete

• Other outcome

  Baseline

• Other outcome

  Baseline

Study Arms (2)

Music therapy

EXPERIMENTAL

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.

Behavioral: Music therapy

Control

NO 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.

Interventions

Music therapy BEHAVIORAL

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.

Music therapy

Eligibility Criteria

• Age: 27 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestation age 27-33 weeks (maternal dates or early fetal ultrasound)
• Is not on ventilators
• Written informed consent forms has been signed from the infant's legal guardian

You may not qualify if:

• Infants with congenital abnormalities
• Severe intraventricular hemorrhage, with ventriculomegaly or parenchymal hemorrhage
• Infants with known or suspected prenatal exposure to substance
• Infants receiving palliative care at NICU
• Infants who are on ventilators
• Infants whose legal guardian did not sign the consent forms

Sponsors & Collaborators

• Saskatchewan Health Authority - Regina Area: lead
• University of Regina: collaborator

Study Sites (1)

Regina General Hospital, Neonatal Intensive Care Unit, Deaprtment of Pediatrics

Regina, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jayalakshmi Bodani

  Saskatchewan Health Authority - Regina Area

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 19, 2020
• Study Start: January 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)