Language Development, Neurocognitive Dysfunction
Conditions
Keywords
Kangaroo care, MEG, AERP, preterm infant
Brief summary
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
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)
Interventions
BEHAVIORALSinging
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.
Sponsors
Helsinki University Central Hospital
Karolinska University Hospital
University of Helsinki
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors do not know the intervention that took place before outcome assessed
Intervention model description
In Helsinki, block randomization, one intervention at the time in the hospital. In Stockholm, both groups simultaneously cared in the hospital
Eligibility
Sex/Gender
ALL
Age
7 Days to 6 Weeks
Healthy volunteers
No
Inclusion criteria
* preterm infants at 30th gestational week capable of being in Kangaroo care
Exclusion criteria
* intensive care preventing Kangaroo care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Auditory cortical responses | Age corresponding to term, ie 40 gestational weeks | 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. |
| Parental anxiety | 3 months age | 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, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurocognitive development, language development | 2 year of age | 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. |
Outcome results
None listed