Clinical trial NCT04314440: Cognitive Processing in Preterm Infants and NICU Music Therapy
Official title: Cognitive Processing in Preterm Infants and NICU Music Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Other Preterm Infants
Keywords: Cognitive
Preterm
Infants
Music
Therapy
NICU
Lead sponsor: Saskatchewan Health Authority - Regina Area
Sponsor class: OTHER
Collaborators: name: University of Regina
First posted: 2020-03-19
Enrollment: 102
Sex: ALL
Minimum age (years): 27
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time looking at a familiar stimulus
timeFrame: 18 - 24 months
Secondary outcomes:
measure: Physiological measure
timeFrame: 15 minutes,before, during, after music therapy, 6 days a week
measure: Physiological measure
timeFrame: 15 minutes,before, during, after music therapy, 6 days a week
measure: Physiological measure
timeFrame: 15 minutes,before, during, after music therapy, 6 days a week
measure: Behavioral measure
timeFrame: Before to after music therapy 6 days a week
measure: Behavioral measure
timeFrame: Before to after music therapy 6 days a week
measure: Behavioral measure
timeFrame: Before to after music therapy 6 days a week
measure: Behavioral measure
timeFrame: Before to after music therapy 6 days a week
Other outcomes:
measure: Other outcomes
timeFrame: Baseline to 3 weeks when music therapy is complete
measure: Other outcome
timeFrame: Baseline
measure: Other outcome
timeFrame: Baseline
measure: Other outcome
timeFrame: Baseline
Locations:
city: Regina
country: Canada
facility: Regina General Hospital, Neonatal Intensive Care Unit, Deaprtment of Pediatrics
state: Saskatchewan
Study officials:
affiliation: Saskatchewan Health Authority - Regina Area
name: Jayalakshmi Bodani
role: PRINCIPAL_INVESTIGATOR
References: