<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03795454</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00003181SK</org_study_id>
    <nct_id>NCT03795454</nct_id>
  </id_info>
  <brief_title>Can Singing Kangaroo Improve Outcome of Preterm Infants</brief_title>
  <acronym>SingKang</acronym>
  <official_title>Singing Kangaroos - Infant Care With Combined Auditory Intervention and Kangaroo Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Helsinki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Helsinki</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess whether a musical intervention (maternal/paternal singing) during the skin-to-skin&#xD;
      sessions (Kangaroo care) would improve the language development of the preterm infant.&#xD;
      Infants will be randomized to singing or silence during the Kangaroo care from the age&#xD;
      corresponding to 30th gestational week until term age (40 gestational weeks).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The outcomes are:&#xD;
&#xD;
      a 2- (3-)year neurodevelopmental follow up&#xD;
&#xD;
      - Bayley Scales of Infant and Toddler Development, Third Edition (in Finnish in Finland and&#xD;
      in Swedish in Sweden)&#xD;
&#xD;
      At the age corresponding to term (40 gestational weeks)&#xD;
&#xD;
        -  Auditory event related potentials (AERPs) in electroencephalography (EEG), in Helsinki&#xD;
           cohort&#xD;
&#xD;
        -  Auditory event related magnetic fields in magnetoencephalgraphy (MEG) in Karolinska&#xD;
           cohort&#xD;
&#xD;
        -  Parental stress with The State Trait Anxiety Inventory (STAI)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2013</start_date>
  <completion_date type="Actual">April 6, 2023</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>In Helsinki, block randomization, one intervention at the time in the hospital. In Stockholm, both groups simultaneously cared in the hospital</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Assessors do not know the intervention that took place before outcome assessed</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Auditory cortical responses</measure>
    <time_frame>Age corresponding to term, ie 40 gestational weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parental anxiety</measure>
    <time_frame>3 months age</time_frame>
    <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,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neurocognitive development, language development</measure>
    <time_frame>2 year of age</time_frame>
    <description>&quot;Bayley III&quot; :- Bayley Scales of Infant and Toddler Develoment, Third Edition (in Finnish in Finland and in Swedish in Sweden)&#xD;
- 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&#xD;
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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Neurocognitive Dysfunction</condition>
  <condition>Language Development</condition>
  <arm_group>
    <arm_group_label>Singing Kangaroo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The parent is singing during the skin-to -skin sessions Musical therapeutist gives the instructions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Silent Kangaroo</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The parent is silent during the skin-to -skin sessions Musical therapeutist gives the instructions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Singing</intervention_name>
    <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.</description>
    <arm_group_label>Singing Kangaroo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  preterm infants at 30th gestational week capable of being in Kangaroo care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intensive care preventing Kangaroo care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Days</minimum_age>
    <maximum_age>6 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaija Mikkola, M.D. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helsinki University Central Hospital</affiliation>
  </overall_official>
  <results_reference>
    <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>
    <PMID>35444514</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>34539329</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>37026177</PMID>
  </results_reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>June 1, 2023</last_update_submitted>
  <last_update_submitted_qc>June 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Helsinki</investigator_affiliation>
    <investigator_full_name>Vineta Fellman</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Kangaroo care</keyword>
  <keyword>MEG</keyword>
  <keyword>AERP</keyword>
  <keyword>preterm infant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Depending on the AERP and MEG results there might be a need/wish to share individual anonymised data</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03795454
org study id: IRB00003181SK
nct id: NCT03795454
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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)
allocation: Randomized
intervention model: Sequential Assignment
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
masking: Single (Outcomes Assessor)
masking description: Assessors do not know the intervention that took place before outcome assessed
measure: Auditory cortical responses
time frame: Age corresponding to term, ie 40 gestational weeks
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.
measure: Parental anxiety
time frame: 3 months age
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,
measure: Neurocognitive development, language development
time frame: 2 year of age
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.
arm group label: Singing Kangaroo
arm group type: Experimental
description: The parent is singing during the skin-to -skin sessions Musical therapeutist gives the instructions
arm group label: Silent Kangaroo
arm group type: No Intervention
description: The parent is silent during the skin-to -skin sessions Musical therapeutist gives the instructions
intervention type: Behavioral
intervention name: Singing
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.
arm group label: Singing Kangaroo
criteria: 
gender: All
minimum age: 7 Days
maximum age: 6 Weeks
healthy volunteers: No
last name: Kaija Mikkola, M.D. PhD
role: Principal Investigator
affiliation: Helsinki University Central Hospital
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.
PMID: 35444514
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.
PMID: 34539329
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.
PMID: 37026177
responsible party type: Principal Investigator
investigator affiliation: University of Helsinki
investigator full name: Vineta Fellman
investigator title: professor
mesh term: Cognitive Dysfunction
sharing ipd: No
ipd description: Depending on the AERP and MEG results there might be a need/wish to share individual anonymised data