Can Singing Kangaroo Improve Outcome of Preterm Infants (SingKang)

June 1, 2023 updated by: Vineta Fellman, University of Helsinki

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • intensive care preventing Kangaroo care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Age corresponding to term, ie 40 gestational weeks
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,
3 months age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurocognitive development, language development
Time Frame: 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.
2 year of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Karolinska University Hospital
Helsinki University Central Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2013

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

April 6, 2023

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

January 4, 2019

First Posted (Actual)

January 7, 2019

Study Record Updates

Last Update Posted (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00003181SK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Depending on the AERP and MEG results there might be a need/wish to share individual anonymised data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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