MusicHyperBrain Study With Preterm Infants and Their Parents
Primary Purpose
Pre-Term
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Creative Music Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pre-Term focused on measuring music therapy, preterm infants, preterm parents, synchronization, hyperscanning, NIRS, HRV, oxyPrem
Eligibility Criteria
Inclusion Criteria:
- Clinically stable preterm infants (no invasive cardiovascular or ventilation support)
- age: 7-21 days of life
- born with 32 0/7 ≤ 36 6/7 weeks of gestation
- mentally stable parents of the included infants
Exclusion Criteria:
- admission for palliative care
- congenital malformation
- parental psychiatric disorders
- parental language barriers
Sites / Locations
- University Hospital ZurichRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Creative Music Therapy
Arm Description
20 minutes of infant-directed singing in lullaby-style accompanied with the monochord for preterm infant and parent during kangaroo-care
Outcomes
Primary Outcome Measures
Inter-personal synchronization of cerebral oxygenation and hemoglobin concentration
Inter-personal synchronization (determined by the time-dependent coherence calculated via Wavelet transform coherence) of cerebral oxygenation (StO2 in %) and total hemoglobin concentration ([tHb] in relative µM) time-series in the brain between the infant and the parent as well as the infant and the music therapist measured by functional near-infrared spectroscopy (fNIRS) neuroimaging with a commercially available device approves for clinical applications (OxyPrem) in the left auditory and prefrontal cortex. Both devices provide similar measurements of cerebral oxygenation and hemodynamics, i.e. relative changes in the concentration of oxyhemoglobin ([O2Hb] in relative µM) and deoxyhemoglobin ([HHb] in relative µM). These time-series will be first pre-processed (removal of artifacts, band-pass filtered (0.01-0.5 Hz)) and then analyzed (Wavelet coherence and subsequent statistical analysis via a generalized additive model and Bayesian analysis).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05383586
Brief Title
MusicHyperBrain Study With Preterm Infants and Their Parents
Official Title
Inter-personal Brain Coupling Between Preterm Infants, Their Parents and a Musician During Creative Music Therapy Using Functional Near-infrared Imaging (fNIRI) Hyperscanning
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Inter-personal brain coupling between preterm infants, their parents and a musician during Creative Music Therapy using functional near-infrared imaging (fNIRI) hyperscanning and systemic physiology measurements
Detailed Description
Background Preterm infants represent a growing population in health care. Unfortunately, many infants suffer from neurodevelopmental impairments that persist into adolescence and adulthood. Besides other risk factors, auditory deprivation (e.g., the lack of exposure to regular intrauterine rhythms of the maternal heartbeat and the maternal voice), and the overwhelming stressful auditory environment of an intensive care unit may negatively impact brain maturation. Studies showed that infant-parent separation can impede the bidirectional development of physical, emotional, and psychological bonds between parents and their infants. Brain development is linked to nurturing social contact and early auditory experience, as demonstrated by human and animal studies. New studies showed, music is promoting neurobiological processes and neuronal learning in the human brain, which starts before birth.
Rationale Creative Music Therapy (CMT) provides meaningful interactions and a nurturing enrichment of the auditory environment by infant-directed singing in lullaby-style. Positive short-term music therapy outcomes (i.e., arousal, behavior, respiratory rate, maternal anxiety) have been shown in several reviews. Preliminary results of a recent pilot feasibility randomized controlled trial (RCT) suggest that functional brain connectivity as measured by resting-state functional magnet resonance imaging seems to have a possible early beneficial effect of CMT which manifests in (1) lower thalamo-cortical processing delay, (2) stronger functional networks, and (3) higher functional integration in predominantly left prefrontal, supplementary motor and inferior temporal brain regions. Depressive symptoms may be decreased and physical connectedness increased between infants and their parents with CMT. However, real time evaluation of CMT's possible immediate effect on the brain activity in infants and inter-personal synchronization processes between parents and infants have not been conducted yet.
The primary objective is to explore if CMT:
Improves inter-personal interaction between the infant, the parent (i.e. the mother or father) and the music therapist assessed via cerebral oxygenation synchronization between the infant and parent as well as the infant and the music therapist in the left auditory cortex and frontal cortex.
The secondary objectives are to explore if CMT:
synchronizes inter-personal emotional/ stress responses between infant, parents (and music therapist)
improves/ regulates brain activity in the infants' left auditory cortex and frontal cortex (evidenced by less fluctuations of cerebral hemodynamics and oxygenation)
reduces stress in the infants
reduces stress in the parents (mother or father)
Additionally, we aim to explore the parental perspective of CMT and their study participation.
Primary endpoint*:
Inter-personal synchronization of cerebral oxygenation and hemoglobin concentration in the brain between the infant and the parent as well as the infant and the music therapist measured by functional near-infrared spectroscopy (fNIRS) neuroimaging with a commercially available device approves for clinical applications (OxyPrem) in the left auditory and prefrontal cortex
Major secondary endpoints*:
Inter-personal synchronization/ coupling of systemic physiology (emotional/ stress responses) in the infant and the parent as well as in the infant and the music therapist measured by systemic physiological parameters (heart rate (HR), electrodermal activity (EDA), heart rate variability (HRV), respiration rate (RR))
Cerebral oxygenation activation/ regulation in the infant measured by fNIRS neuroimaging with OxyPrem in the left auditory and prefrontal cortex
Stress level in the infants measured by systemic parameters (HR, EDA, HRV)
Stress level in the parents measured by systemic parameters (EDA, HRV)
Parental perspective of CMT and study participation
15 minutes before CMT (5 minutes without kangaroo/ 10 minutes in kangaroo), 20 minutes during kangaroo with CMT, and 10 minutes after CMT (10 minutes in kangaroo/ without kangaroo)/ first session of CMT during neonatal intensive care hospitalization in the second/third week after the preterm infant's birth
Intervention:
Once/second time 20 minutes CMT: entrained infant-directed live lullaby singing, accompanied with the vibro-acoustic monochord provided by the music therapist for infant and parents in kangaroo care as described in the published clinical practice protocol.
N= 20 infant-parent couples (effect size: 1.4; significance level: 0.05; power: 0.8)
Study duration:
Preparatory phase (months): 3 months
First patient to last patient in/recruitment/ intervention phase: 12 months
analysis: 2 months
Preparation publication: 3 months Duration of the entire trial (preparatory phase + study phase): 18 months
Statistical considerations:
Brain-to-brain coupling will be determined by coherence analysis based on the fNIRS signals measured. The time-dependent coherence changes will be analyzed statistically in order to see stat. significant changes during the task compared to the baseline. Synchronization of systemic physiological signals will be determined with the same approach. Statistical analysis will be performed with ANOVA and generalized additive models (GMAs).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Term
Keywords
music therapy, preterm infants, preterm parents, synchronization, hyperscanning, NIRS, HRV, oxyPrem
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One single group will be included with a pre-during-post intervention design.
Masking
None (Open Label)
Masking Description
The intervention can not be masked since it is provided with live music to the infants and parents.
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Creative Music Therapy
Arm Type
Experimental
Arm Description
20 minutes of infant-directed singing in lullaby-style accompanied with the monochord for preterm infant and parent during kangaroo-care
Intervention Type
Other
Intervention Name(s)
Creative Music Therapy
Intervention Description
Creative Music Therapy is provided during kangaroo-care. It is an individualized, family- centered approach offering infant-directed humming and singing accompanied with the monochord.
Primary Outcome Measure Information:
Title
Inter-personal synchronization of cerebral oxygenation and hemoglobin concentration
Description
Inter-personal synchronization (determined by the time-dependent coherence calculated via Wavelet transform coherence) of cerebral oxygenation (StO2 in %) and total hemoglobin concentration ([tHb] in relative µM) time-series in the brain between the infant and the parent as well as the infant and the music therapist measured by functional near-infrared spectroscopy (fNIRS) neuroimaging with a commercially available device approves for clinical applications (OxyPrem) in the left auditory and prefrontal cortex. Both devices provide similar measurements of cerebral oxygenation and hemodynamics, i.e. relative changes in the concentration of oxyhemoglobin ([O2Hb] in relative µM) and deoxyhemoglobin ([HHb] in relative µM). These time-series will be first pre-processed (removal of artifacts, band-pass filtered (0.01-0.5 Hz)) and then analyzed (Wavelet coherence and subsequent statistical analysis via a generalized additive model and Bayesian analysis).
Time Frame
50 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinically stable preterm infants (no invasive cardiovascular or ventilation support)
age: 7-21 days of life
born with 32 0/7 ≤ 36 6/7 weeks of gestation
mentally stable parents of the included infants
Exclusion Criteria:
admission for palliative care
congenital malformation
parental psychiatric disorders
parental language barriers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Friederike Haslbeck, PhD
Phone
+41 78 708 1862
Email
friederike.haslbeck@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Felix Scholkmann, PD, PhD
Phone
+41 44 255 53 45
Email
felix.scholkmann@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Bassler, Prof.
Organizational Affiliation
University Hospital Zurich, Department Neonatology
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Friederike B Haslbeck, PhD
Phone
+41 78 708 1862
Email
friederike.haslbeck@usz.ch
First Name & Middle Initial & Last Name & Degree
Dirk Bassler, Prof.
Phone
+41 44 2551111
Email
dirk.bassler@usz.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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MusicHyperBrain Study With Preterm Infants and Their Parents
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