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Can Singing Kangaroo Improve Outcome of Preterm Infants (SingKang)

Primary Purpose

Neurocognitive Dysfunction, Language Development

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Singing
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neurocognitive Dysfunction focused on measuring Kangaroo care, MEG, AERP, preterm infant

Eligibility Criteria

7 Days - 6 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • intensive care preventing Kangaroo care

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Singing Kangaroo

    Silent Kangaroo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    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,

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    November 30, 2018
    Last Updated
    June 1, 2023
    Sponsor
    University of Helsinki
    Collaborators
    Helsinki University Central Hospital, Karolinska University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03795454
    Brief Title
    Can Singing Kangaroo Improve Outcome of Preterm Infants
    Acronym
    SingKang
    Official Title
    Singing Kangaroos - Infant Care With Combined Auditory Intervention and Kangaroo Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    May 3, 2013 (Actual)
    Primary Completion Date
    May 31, 2018 (Actual)
    Study Completion Date
    April 6, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Helsinki
    Collaborators
    Helsinki University Central Hospital, Karolinska University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neurocognitive Dysfunction, Language Development
    Keywords
    Kangaroo care, MEG, AERP, preterm infant

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    In Helsinki, block randomization, one intervention at the time in the hospital. In Stockholm, both groups simultaneously cared in the hospital
    Masking
    Outcomes Assessor
    Masking Description
    Assessors do not know the intervention that took place before outcome assessed
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Singing Kangaroo
    Arm Type
    Experimental
    Arm Description
    The parent is singing during the skin-to -skin sessions Musical therapeutist gives the instructions
    Arm Title
    Silent Kangaroo
    Arm Type
    No Intervention
    Arm Description
    The parent is silent during the skin-to -skin sessions Musical therapeutist gives the instructions
    Intervention Type
    Behavioral
    Intervention Name(s)
    Singing
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Auditory cortical responses
    Description
    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.
    Time Frame
    Age corresponding to term, ie 40 gestational weeks
    Title
    Parental anxiety
    Description
    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,
    Time Frame
    3 months age
    Secondary Outcome Measure Information:
    Title
    Neurocognitive development, language development
    Description
    "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.
    Time Frame
    2 year of age

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Days
    Maximum Age & Unit of Time
    6 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: preterm infants at 30th gestational week capable of being in Kangaroo care Exclusion Criteria: intensive care preventing Kangaroo care
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kaija Mikkola, M.D. PhD
    Organizational Affiliation
    Helsinki University Central Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Depending on the AERP and MEG results there might be a need/wish to share individual anonymised data
    Citations:
    PubMed Identifier
    35444514
    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.
    Results Reference
    result
    PubMed Identifier
    34539329
    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.
    Results Reference
    result
    PubMed Identifier
    37026177
    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.
    Results Reference
    result

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