Can Singing Kangaroo Improve Outcome of Preterm Infants

Language Development Clinical Trial

— SingKang  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03795454
• Other study ID #: IRB00003181SK
• Status: Completed
• Phase: N/A
• Start date: May 3, 2013
• Est. completion date: April 6, 2023

Study information

• Verified date: June 2023
• Source: University of Helsinki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 6, 2023
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Days to 6 Weeks

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• intensive care preventing Kangaroo care

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Language Development
• Neurocognitive Dysfunction

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Helsinki	Helsinki University Central Hospital, Karolinska University Hospital

References & Publications (3)

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 Apr 6. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Age corresponding to term, ie 40 gestational weeks
Primary	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,	3 months age
Secondary	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.	2 year of age