Clinical trial NCT03795454: Can Singing Kangaroo Improve Outcome of Preterm Infants
Official title: Singing Kangaroos - Infant Care With Combined Auditory Intervention and Kangaroo Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurocognitive Dysfunction
Language Development
Keywords: Kangaroo care
MEG
AERP
preterm infant
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Karolinska University Hospital
First posted: 2019-01-07
Enrollment: 140
Sex: ALL
Minimum age (years): 7
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: In Helsinki, block randomization, one intervention at the time in the hospital. In Stockholm, both groups simultaneously cared in the hospital
Primary purpose: SUPPORTIVE_CARE

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)

Eligibility criteria: Inclusion Criteria:

* preterm infants at 30th gestational week capable of being in Kangaroo care

Exclusion Criteria:

* intensive care preventing Kangaroo care

Primary outcomes:
measure: Auditory cortical responses
timeFrame: Age corresponding to term, ie 40 gestational weeks
measure: Parental anxiety
timeFrame: 3 months age
Secondary outcomes:
measure: Neurocognitive development, language development
timeFrame: 2 year of age
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Kaija Mikkola, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Partanen E, Martensson G, Hugoson P, Huotilainen M, Fellman V, Aden U. Auditory Processing of the Brain Is Enhanced by Parental Singing for Preterm Infants. Front Neurosci. 2022 Apr 4;16:772008. doi: 10.3389/fnins.2022.772008. eCollection 2022.
citation: Kostilainen K, Partanen E, Mikkola K, Wikstrom V, Pakarinen S, Fellman V, Huotilainen M. Repeated Parental Singing During Kangaroo Care Improved Neural Processing of Speech Sound Changes in Preterm Infants at Term Age. Front Neurosci. 2021 Sep 3;15:686027. doi: 10.3389/fnins.2021.686027. eCollection 2021.
citation: Kostilainen K, Hugoson P, Haavisto A, Partanen E, Mikkola K, Huotilainen M, Pakarinen S, Furmark C, Aden U, Fellman V. No impact of parental singing during the neonatal period on cognition in preterm-born children at 2-3 years. Acta Paediatr. 2023 Jul;112(7):1471-1477. doi: 10.1111/apa.16788. Epub 2023 Apr 25.