Can Singing Kangaroo Improve Outcome of Preterm Infants

NCT03795454 | Completed

• 1 other identifier: IRB00003181SK
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Neurocognitive Dysfunction; Language Development

Keywords

Kangaroo care; MEG; AERP; preterm infant

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Neurocognitive development, language development

  2 year of age

Study Arms (2)

Singing Kangaroo

EXPERIMENTAL

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

Behavioral: Singing

Silent Kangaroo

NO INTERVENTION

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

Interventions

Singing BEHAVIORAL

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.

Singing Kangaroo

Eligibility Criteria

• Age: 7 Days - 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• intensive care preventing Kangaroo care

Sponsors & Collaborators

• University of Helsinki: lead
• Helsinki University Central Hospital: collaborator
• Karolinska University Hospital: collaborator

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Cognition Disorders; Premature Birth

Interventions

Singing

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phonation; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Kaija Mikkola, M.D. PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors do not know the intervention that took place before outcome assessed
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

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

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: January 7, 2019
• Study Start: May 3, 2013
• Primary Completion: May 31, 2018
• Study Completion: April 6, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share