Neurocognitive DysfunctionSingKangNCT03795454
Can Singing Kangaroo Improve Outcome of Preterm Infants
A study testing Singing in people with Neurocognitive Dysfunction and Language Development, run by University of Helsinki.
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. Read more about this study
- Who is it for?
- Ages 7 days to 6 weeks
- Conditions the study is for
- Neurocognitive Dysfunction, Language Development
- What is being tested?
- Singing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 3 May 2013to 6 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 6 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infants at 30th gestational week capable of being in Kangaroo care
Who cannot join
- intensive care preventing Kangaroo care
About this study
Official title: Singing Kangaroos - Infant Care With Combined Auditory Intervention and Kangaroo Care
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).
Read the 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)
- Conditions
- Neurocognitive Dysfunction, Language Development
- Being tested
- Singing
- Keywords
- Kangaroo care, MEG, AERP, preterm infant
- Medical subject headings
- Cognition Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SingingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Singing Kangaroo | Experimental | The parent is singing during the skin-to -skin sessions Musical therapeutist gives the instructions Receives: Behavioral: Singing |
| Silent Kangaroo | No intervention | The parent is silent during the skin-to -skin sessions Musical therapeutist gives the instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Age corresponding to term, ie 40 gestational weeks
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,
Measured: 3 months age
Secondary outcomes (1)
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.
Measured: 2 year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start3 May 2013
- Primary completion31 May 2018
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- In Helsinki, block randomization, one intervention at the time in the hospital. In Stockholm, both groups simultaneously cared in the hospital
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vineta Fellman, University of Helsinki
- Investigators
- Kaija Mikkola, M.D. PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795454
- Sponsor's protocol ID
- IRB00003181SK
- Acronym
- SingKang
- Status last verified
- Jun 2023
- First submitted
- 30 Nov 2018
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Depending on the AERP and MEG results there might be a need/wish to share individual anonymised data
Publications
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.
PubMed 35444514Kostilainen 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.
PubMed 34539329Kostilainen 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.
PubMed 37026177
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Singing Kangaroos - Infant Care With Combined Auditory Intervention and Kangaroo Care
- ClinicalTrials.gov ID
- NCT03795454
- Acronym / sponsor ID
- SingKang / IRB00003181SK
- Conditions
- Neurocognitive Dysfunction, Language Development
- Keywords
- Kangaroo care, MEG, AERP, preterm infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Karolinska University Hospital
- Study start
- 3 May 2013 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In Helsinki, block randomization, one intervention at the time in the hospital. In Stockholm, both groups simultaneously cared in the hospital
| Arm | Type | Receives |
|---|---|---|
| Singing Kangaroo | Experimental | Behavioral: SingingThe parent is singing during the skin-to -skin sessions Musical therapeutist gives the instructions |
| Silent Kangaroo | No intervention | –The parent is silent during the skin-to -skin sessions Musical therapeutist gives the instructions |
Who may qualify
- Ages
- 7 days to 6 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preterm infants at 30th gestational week capable of being in Kangaroo care
Key exclusion criteria (1 listed)
- intensive care preventing Kangaroo care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SingingInfant-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. | Behavioural | Singing Kangaroo |
Primary outcome
Auditory cortical responses
Time frame: Age corresponding to term, ie 40 gestational weeks
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
Time frame: 3 months age
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,
1 secondary outcome
Neurocognitive development, language development
Time frame: 2 year of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Results publication: PubMed 35444514Partanen 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 publication: PubMed 34539329Kostilainen 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 publication: PubMed 37026177Kostilainen 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.
- Individual participant dataSharing planned: No. Depending on the AERP and MEG results there might be a need/wish to share individual anonymised data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaija Mikkola, M.D. PhD principal investigator
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Singing in people with Neurocognitive Dysfunction and Language Development, run by University of Helsinki.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory cortical responses (time frame: Age corresponding to term, ie 40 gestational weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03795454, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.