Cognitive Processing in Preterm Infants and NICU Music Therapy

Other Preterm Infants Clinical Trial

— NICU-MT  

Official title:

Cognitive Processing in Preterm Infants and NICU Music Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04314440
• Other study ID #: REB15-100
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Saskatchewan Health Authority - Regina Area
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

Following previous research, our hypothesis is that infants in the experimental group will display significantly more positive scores on a collection of physiological and behavioural measurements. The stimuli used at each age will be targeted to the infants' developmental level. Bayley Scales of Infant Development will also be administered at 18 - 24 months as part of high risk infant follow up. These data will be included in the analysis for outcome measurement. While seated in a high-chair or their parent's lap, infants will be habituated to a series of images of a particular shape (e.g., a triangle), while their looking time to each stimulus is measured. Each image during habituation will be a unique token of the category (i.e., all different triangles). Habituation will be individually determined, and defined as cumulative looking across three successive trials that is 50% than cumulative looking across the first three trials. Following habituation, infants will be shown a novel token of the habituation shape (e.g., a new triangle) and a novel shape (e.g., a square), in counterbalanced order. If infants recognize the category change, they should look longer at novel category compared to the novel token. For each test, two dependent measures will be sampled: rate of habituation and amount of dishabituation to the novel category. Mixed ANOVA and paired t-tests will be used to analyze the data. As preterm infants have been shown to be delayed on these kinds of tasks, we hypothesize that the experimental group will habituate to each category faster, and/or display stronger dishabituation scores compared to the preterm. We will also use multiple regression analyses to examine relations between the NICU physiological and behavioural measures and the cognitive measures. We hypothesize that infants who most strongly benefited from their therapies in the NICU will display the most advanced cognitive abilities. An intention-to-treat- analysis will be performed for cognitive measures as well. The cognitive assessment at 2 and 4 months that were to be carried out at the Developmental Lab at University of Regina is now canceled due to feasibility concerns.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 27 Weeks to 33 Weeks

Eligibility

Inclusion Criteria:

1. Gestation age 27-33 weeks (maternal dates or early fetal ultrasound)

2. Is not on ventilators

3. Written informed consent forms has been signed from the infant's legal guardian

Exclusion Criteria:

1. Infants with congenital abnormalities

2. Severe intraventricular hemorrhage, with ventriculomegaly or parenchymal hemorrhage

3. Infants with known or suspected prenatal exposure to substance

4. Infants receiving palliative care at NICU

5. Infants who are on ventilators

6. Infants whose legal guardian did not sign the consent forms

Related Conditions & MeSH terms

• Other Preterm Infants
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Canada	Regina General Hospital, Neonatal Intensive Care Unit, Deaprtment of Pediatrics	Regina	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
Saskatchewan Health Authority - Regina Area	University of Regina

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other outcomes	Average difference in weight gain (total calorie intake) between experimental and control group	Baseline to 3 weeks when music therapy is complete
Other	Other outcome	Average difference in length of hospitalization between experimental group and control group	Baseline
Other	Other outcome	Average difference in neurological assessment score between experimental group and control group	Baseline
Other	Other outcome	Average difference in hearing assessment between experimental group and control group	Baseline
Primary	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	Physiological measure	Average difference in heart rate before music therapy to after music therapy from before to during and from during to after music therapy.	15 minutes,before, during, after music therapy, 6 days a week
Secondary	Physiological measure	Average difference in breathing rate before music therapy to after music therapy from before to during and from during to after music therapy.	15 minutes,before, during, after music therapy, 6 days a week
Secondary	Physiological measure	Average difference in oxygen saturation before music therapy to after music therapy from before to during and from during to after music therapy.	15 minutes,before, during, after music therapy, 6 days a week
Secondary	Behavioral measure	Difference in sleep between experimental and control group	Before to after music therapy 6 days a week
Secondary	Behavioral measure	Difference in apnea between experimental and control group	Before to after music therapy 6 days a week
Secondary	Behavioral measure	Difference in Bradycardia (number and severity) between experimental and control group	Before to after music therapy 6 days a week
Secondary	Behavioral measure	Difference in de-saturation degree of it between experimental and control group	Before to after music therapy 6 days a week