Can Singing Kangaroo Improve Outcome of Preterm Infants

Not Applicable

Completed

• Conditions: Language Development; Neurocognitive Dysfunction
• Interventions: Behavioral: Singing

• Registration Number: NCT03795454
• Lead Sponsor: University of Helsinki

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).

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 Timeline

• Study Start: 2013-05-03
• Primary Completion: 2018-05-31
• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2019-01-04
• Study First Posted: 2019-01-07
• Study Completion: 2023-04-06
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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

Exclusion Criteria

• intensive care preventing Kangaroo care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Singing Kangaroo	Singing	The parent is singing during the skin-to -skin sessions Musical therapeutist gives the instructions

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.