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Completed

NCT Number: NCT02434224

Creative Music Therapy for Premature Infants

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.

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Key information

Age range

7 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Music Therapy

Procedure

2 to 3 sessions per week of individualized creative music therapy

Primary outcomes

  1. 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

Secondary outcomes

  1. Mental Development Index (Bayley III)

    Time frame: 24 months corrected for prematurity

    Bayley scales III (MDI)

  2. Intelligence Quotient

    Time frame: 5 years

    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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 5, 2015
Registry last updated
Feb 5, 2019

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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