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Completed

NCT Number: NCT03795454

Can Singing Kangaroo Improve Outcome of Preterm Infants

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).

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Key information

Conditions

Neurocognitive Dysfunction Cognition Disorders Female Urogenital Diseases and Pregnancy Complications Language Development Mental Disorders Neurocognitive Disorders Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

7 day–6 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • intensive care preventing Kangaroo care

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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,

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Helsinki University Central Hospital
  • Karolinska University Hospital

Registry information

Official study title

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

Acronym: SingKang

Important dates

Study start
2013
Primary completion
2018
Study completion
2023
First posted
Jan 7, 2019
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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