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.
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.
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.
- Conditions
- Developmental Delay (Disorder)
- 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 group | Role | What they receive |
|---|---|---|
| music therapy | Experimental | 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. Receives: Procedure: Music Therapy |
| control | No intervention | standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Mental Development Index (Bayley III)
Bayley scales III (MDI)
Measured: 24 months corrected for prematurity
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.
- First posted5 May 2015 (estimated)
- Study start1 Jan 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Developmental Delay (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans U Bucher, Prof., Study chair, University of Zurich
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 34222141Haslbeck 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creative Music Therapy for Premature Infants: Testing a Possible Influence on Brain Structure, Function and Neurobehavioral Outcome
- ClinicalTrials.gov ID
- NCT02434224
- Acronym / sponsor ID
- 2014-0655
- Conditions
- Developmental Delay (Disorder)
- Keywords
- Music therapy, premature infant, brain development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music therapy | Experimental | Procedure: Music Therapytwo 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. |
| control | No intervention | –standard care |
Who may qualify
- Ages
- 7 to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Born before 32 weeks of gestational age
- Clinically stable
- Chronological age ≥ 7 days of life
- Informed written parental consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Therapy2 to 3 sessions per week of individualized creative music therapy | Procedure or surgery | music therapy |
Primary outcome
Brain volume
Time frame: 40 gestational weeks
3D magnetic resonance volumetric analysis: volumes of white matter (myelinated and unmyelinated) and grey matter volume will be evaluated
2 secondary outcomes
Mental Development Index (Bayley III)
Time frame: 24 months corrected for prematurity
Intelligence Quotient
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: PubMed 34222141Haslbeck 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.
- Derived from this study: PubMed 28975039Haslbeck 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans U Bucher, Prof. study chair
University of Zurich
1 site in 1 country: see every site and its status.
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.