SingKang: Can Singing Kangaroo Improve Outcome of Preterm Infants

Sponsor

University of Helsinki (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03795454

Collaborator

Helsinki University Central Hospital (Other), Karolinska University Hospital (Other)

140

Enrollment

Arms

115.9

Anticipated Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Neurocognitive Dysfunction Language Development	Behavioral: Singing	N/A

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

Study Type:

Interventional

Actual Enrollment :

140 participants

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

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Supportive Care

Official Title:

Singing Kangaroos - Infant Care With Combined Auditory Intervention and Kangaroo Care

Actual Study Start Date :

May 3, 2013

Actual Primary Completion Date :

May 31, 2018

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Singing Kangaroo The parent is singing during the skin-to -skin sessions Musical therapeutist gives the instructions	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.
No Intervention: Silent Kangaroo The parent is silent during the skin-to -skin sessions Musical therapeutist gives the instructions

Arm

Intervention/Treatment

Experimental: Singing Kangaroo

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

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.

No Intervention: Silent Kangaroo

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

Outcome Measures

Primary Outcome Measures

Auditory cortical responses [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 [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,

Secondary Outcome Measures

Neurocognitive development, language development [2 year of age]
"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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

intensive care preventing Kangaroo care

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Helsinki
Helsinki University Central Hospital
Karolinska University Hospital

Investigators

Principal Investigator: Kaija Mikkola, M.D. PhD, Helsinki University Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Vineta Fellman, professor, University of Helsinki

ClinicalTrials.gov Identifier:

NCT03795454

Other Study ID Numbers:

IRB00003181SK

First Posted:

Jan 7, 2019

Last Update Posted:

May 27, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Vineta Fellman, professor, University of Helsinki

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of May 27, 2022