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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03795454
Other study ID # IRB00003181SK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2013
Est. completion date April 6, 2023

Study information

Verified date June 2023
Source University of Helsinki
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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)


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date April 6, 2023
Est. primary completion date May 31, 2018
Accepts healthy volunteers No
Gender All
Age group 7 Days to 6 Weeks
Eligibility Inclusion Criteria: - preterm infants at 30th gestational week capable of being in Kangaroo care Exclusion Criteria: - intensive care preventing Kangaroo care

Study Design


Intervention

Behavioral:
Singing
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.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
University of Helsinki Helsinki University Central Hospital, Karolinska University Hospital

References & Publications (3)

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 Apr 6. — View 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 — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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