Can Singing Kangaroo Improve Outcome of Preterm Infants

Study Overview
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Brief Summary
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To assess whether a musical intervention (maternal/paternal singing) during the skin-to-skin sessions (Kangaroo care) would improve the language development of the preterm infant. Infants will be randomized to singing or silence during the Kangaroo care from the age corresponding to 30th gestational week until term age (40 gestational weeks).

Detailed Description
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The outcomes are: a 2- (3-)year neurodevelopmental follow up - Bayley Scales of Infant and Toddler Development, Third Edition (in Finnish in Finland and in Swedish in Sweden) At the age corresponding to term (40 gestational weeks) Auditory event related potentials (AERPs) in electroencephalography (EEG), in Helsinki cohort Auditory event related magnetic fields in magnetoencephalgraphy (MEG) in Karolinska cohort Parental stress with The State Trait Anxiety Inventory (STAI)

Official Title
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Singing Kangaroos - Infant Care With Combined Auditory Intervention and Kangaroo Care

Conditions
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Neurocognitive Dysfunction, Language Development

Intervention / Treatment
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* Behavioral: Singing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preterm infants at 30th gestational week capable of being in Kangaroo care Exclusion Criteria: intensive care preventing Kangaroo care

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 6 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: In Helsinki, block randomization, one intervention at the time in the hospital. In Stockholm, both groups simultaneously cared in the hospital
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Singing Kangaroo<br>The parent is singing during the skin-to -skin sessions Musical therapeutist gives the instructions | Behavioral: Singing<br>* Infant-directed singing and singing of self-invented songs, especially songs emerging from the interaction with the infant, are especially encouraged. The families will receive audio material of children's songs, lullabies, and lyrics of the lullabies to support them if they feel unable to accomplish the task otherwise.<br>|
| No Intervention: Silent Kangaroo<br>The parent is silent during the skin-to -skin sessions Musical therapeutist gives the instructions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Auditory cortical responses | Auditory Event-Related Potentials (AERPs) at full-term age will be recorded with multi-feature paradigm (MFP), in which the mismatch negativity (MMN) to 5 speech-related auditory features can be recorded in a short time period. | Age corresponding to term, ie 40 gestational weeks | 
| Parental anxiety | Parents' state anxiety is measured using the STAI (State-Trait Anxiety Inventory, Spielberger, 1983) with 20 self-descriptive statements once per week until the infant leaves the hospital and once in two weeks until the infant reaches the corrected age of 3 months, | 3 months age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive development, language development | Bayley III :- Bayley Scales of Infant and Toddler Develoment, Third Edition (in Finnish in Finland and in Swedish in Sweden) - The following scales will be used: Cognitive, Language, Motor, Language scale includes Expressive Language and Receptive Language Motor scale includes Fine Motorics and Gross Motorics All scale ranges will be included (i.e., minimum and maximum scores) required to interpret any values. For example, if the *total* score is reported, the *total* range should be provided. If *subscale* scores are reported, the range for each *subscale* should be provided. | 2 year of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AERP, preterm infant, Kangaroo care, MEG