Can Singing Kangaroo Improve Outcome of Preterm Infants

NCT ID: NCT03795454

Last Updated: 2023-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-03

Study Completion Date

2023-04-06

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)

Conditions

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Neurocognitive Dysfunction Language Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

In Helsinki, block randomization, one intervention at the time in the hospital. In Stockholm, both groups simultaneously cared in the hospital
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Assessors do not know the intervention that took place before outcome assessed

Study Groups

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Singing Kangaroo

The parent is singing during the skin-to -skin sessions Musical therapeutist gives the instructions

Group Type EXPERIMENTAL

Singing

Intervention Type BEHAVIORAL

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.

Silent Kangaroo

The parent is silent during the skin-to -skin sessions Musical therapeutist gives the instructions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

7 Days

Maximum Eligible Age

6 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Vineta Fellman

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kaija Mikkola, M.D. PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

References

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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.

Reference Type RESULT
PMID: 35444514 (View on PubMed)

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.

Reference Type RESULT
PMID: 34539329 (View on PubMed)

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.

Reference Type RESULT
PMID: 37026177 (View on PubMed)

Other Identifiers

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IRB00003181SK

Identifier Type: -

Identifier Source: org_study_id

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