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Creative Music Therapy for Premature Infants

Primary Purpose

Developmental Delay (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Delay (Disorder) focused on measuring Music therapy, premature infant, brain development

Eligibility Criteria

7 Days - 14 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Born before 32 weeks of gestational age
  • Clinically stable
  • Chronological age ≥ 7 days of life
  • Informed written parental consent

Exclusion Criteria:

  • Born after 32 weeks of gestational age (due to a possible too short timeframe for music therapy treatment)
  • Lack of parental consent
  • Admitted a priori for palliative care
  • Genetically defined syndrome
  • Severe congenital malformation adversely affecting life expectancy or neurodevelopment
  • (For the control group only: Regular singing or other kinds of music stimulation by the parents during hospitalization time)

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

music therapy

control

Arm Description

two to three sessions per week: The therapist will stay with one hand on the infants' chest (or back) in order to continuously assess the infants' breathing pattern. Based on and oriented towards the assessed breathing pattern, the infants' behavioral state, facial and gestural expression, the therapist transforms the infants' rhythms and subtle expressions into infant-directed improvised humming.

standard care

Outcomes

Primary Outcome Measures

Brain volume
3D magnetic resonance volumetric analysis: volumes of white matter (myelinated and unmyelinated) and grey matter volume will be evaluated

Secondary Outcome Measures

Mental Development Index (Bayley III)
Bayley scales III (MDI)
Intelligence Quotient
Intelligence quotient (Wechsler Preschool and Primary Scale of Intelligence-Revised, WPPSI-R) to determine long-term development and intelligence. Children will be classified as either being normal or having minor or major impairment.

Full Information

First Posted
March 30, 2015
Last Updated
February 4, 2019
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02434224
Brief Title
Creative Music Therapy for Premature Infants
Official Title
Creative Music Therapy for Premature Infants: Testing a Possible Influence on Brain Structure, Function and Neurobehavioral Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study investigates whether creative music therapy applied to premature infants will facilitate brain growth and development at term equivalent assessed by magnetic resonance imaging. Secondary objective are improvement of neurobehavioral outcomes of premature infants at 24 months, as well as at 5 years of age.
Detailed Description
Premature infants are a highly prevalent and vulnerable group in paediatric care, and face several short- and long-term challenges. Research on brain development in premature infants demonstrates a high incidence of white and grey matter abnormalities and neurobehavioral delay, as well as an increased risk of brain injury. There is growing awareness that premature infants need individualized nurturing interactions with their caregivers while they are in a neonatal intensive care unit (NICU) to support healthy development and prevent future difficulties. One particular intervention that may have considerable potential in the NICU is creative music therapy (CMT), an individualized, interactive, resource- and needs-oriented music therapy approach. Results demonstrate that CMT can facilitate relaxation and stabilization in premature infants; by experiencing inter-subjectivity through music, the infants can be empowered to engage in meaningful and nurturing interactions (Haslbeck, 2013 a,b) . Several researchers (Als, 2012; Trevarthen, 2008; Schore, 2003) have described how interactive and multi-sensory experiences of the fetus particularly facilitate brain development and learning about socio-emotional figures, respectively, in prematurely born infants. It is assumed that positive auditory experiences can promote premature infants' early brain maturation and contribute to their healthy neurodevelopment (Xu et al., 2009). Studies in music and neuroscience have demonstrated that music promotes neurobiological processes and modulates synaptic plasticity, neuronal learning and readjustment in the human brain (Rickard et al., 2005). The individualized approach in active music therapy may especially activate brain structures involved in emotional, sensorimotor and cognitive processing (Koelsch, 2009; Fachner et al., 2012). Since, on one hand, individualized interactive experiences and, on the other hand, music may alter brain development in the fetus and very young infants, the question arises as to whether CMT might actually promote a premature infant's brain development by facilitating nurturing socio-emotional and auditory interactive experiences at the same time. Therefore a randomized, controlled, clinical trial will be conducted. 30 premature infants receive CMT during their hospitalization time and 30 premature infants without music therapy serves as control group. The primary objective is to explore if the experience of CMT in premature infants improves their brain growth and development at 38-42 weeks of corrected gestational age. The main secondary objective is to explore if CMT improves the neurobehavioral outcomes of premature infants at 9 and 24 months, as well as at 5 years of age. Magnetic resonance imaging is used to evaluate the infants' cerebral cortical development and myelination. Electroencephalography (EEG) is used to evaluate the infants' brain function and maturation. Insights into possible long-term and sustainable outcomes will be gained via neuro-developmental follow-up examinations. It is hypothesized that the experience of CMT in neonatal care improves both short- and long-term neurological outcomes. We expect that the experimental group will demonstrate superior brain growth and development at 38-42 weeks of corrected gestational age as well as improved cognitive, behavioral and motor developmental outcomes later on. This paper will introduce first insights and preliminary results of the ongoing study. Strategies and challenges inherent in conducting a controlled clinical trial within this vulnerable group will be discussed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Delay (Disorder)
Keywords
Music therapy, premature infant, brain development

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
music therapy
Arm Type
Experimental
Arm Description
two to three sessions per week: The therapist will stay with one hand on the infants' chest (or back) in order to continuously assess the infants' breathing pattern. Based on and oriented towards the assessed breathing pattern, the infants' behavioral state, facial and gestural expression, the therapist transforms the infants' rhythms and subtle expressions into infant-directed improvised humming.
Arm Title
control
Arm Type
No Intervention
Arm Description
standard care
Intervention Type
Procedure
Intervention Name(s)
Music Therapy
Intervention Description
2 to 3 sessions per week of individualized creative music therapy
Primary Outcome Measure Information:
Title
Brain volume
Description
3D magnetic resonance volumetric analysis: volumes of white matter (myelinated and unmyelinated) and grey matter volume will be evaluated
Time Frame
40 gestational weeks
Secondary Outcome Measure Information:
Title
Mental Development Index (Bayley III)
Description
Bayley scales III (MDI)
Time Frame
24 months corrected for prematurity
Title
Intelligence Quotient
Description
Intelligence quotient (Wechsler Preschool and Primary Scale of Intelligence-Revised, WPPSI-R) to determine long-term development and intelligence. Children will be classified as either being normal or having minor or major impairment.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Born before 32 weeks of gestational age Clinically stable Chronological age ≥ 7 days of life Informed written parental consent Exclusion Criteria: Born after 32 weeks of gestational age (due to a possible too short timeframe for music therapy treatment) Lack of parental consent Admitted a priori for palliative care Genetically defined syndrome Severe congenital malformation adversely affecting life expectancy or neurodevelopment (For the control group only: Regular singing or other kinds of music stimulation by the parents during hospitalization time)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans U Bucher, Prof.
Organizational Affiliation
University of Zurich
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34222141
Citation
Haslbeck FB, Bucher HU, Bassler D, Hagmann C, Natalucci G. Creative Music Therapy and Neurodevelopmental Outcomes in Pre-term Infants at 2 Years: A Randomized Controlled Pilot Trial. Front Pediatr. 2021 Jun 18;9:660393. doi: 10.3389/fped.2021.660393. eCollection 2021.
Results Reference
derived
PubMed Identifier
28975039
Citation
Haslbeck FB, Bucher HU, Bassler D, Hagmann C. Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol. Pilot Feasibility Stud. 2017 Sep 26;3:36. doi: 10.1186/s40814-017-0180-5. eCollection 2017.
Results Reference
derived

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Creative Music Therapy for Premature Infants

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