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Developmental Delay (Disorder)NCT02434224

Creative Music Therapy for Premature Infants

A study testing Music Therapy in people with Developmental Delay (Disorder), run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 14 days
Conditions the study is for
Developmental Delay (Disorder)
What is being tested?
Music Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteSwitzerland
Study dates
1 Jan 2015to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 14 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospital

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Creative Music Therapy for Premature Infants: Testing a Possible Influence on Brain Structure, Function and Neurobehavioral Outcome

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.

Read the 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.

Being tested
Music Therapy
Keywords
Music therapy, premature infant, brain development
Medical subject headings
Developmental Disabilities, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music TherapyProcedure or surgery

    2 to 3 sessions per week of individualized creative music therapy

Study groups in NCT02434224
Study groupRoleWhat they receive
music therapyExperimentaltwo 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.
Receives: Procedure: Music Therapy
controlNo interventionstandard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Brain volume

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

    Measured: 40 gestational weeks

Secondary outcomes (2)
  1. Mental Development Index (Bayley III)

    Bayley scales III (MDI)

    Measured: 24 months corrected for prematurity

  2. 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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2015 (estimated)
  2. Study start1 Jan 2015
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02434224
Sponsor's protocol ID
2014-0655
Status last verified
Feb 2019
First submitted
30 Mar 2015
Last updated
5 Feb 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34222141
  • 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.

    PubMed 28975039

Questions about this trial

What is this clinical trial studying?

A study testing Music Therapy in people with Developmental Delay (Disorder), run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain volume (time frame: 40 gestational weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02434224, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.

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