MusicHyperBrain Study With Preterm Infants and Their Parents

NCT05383586 | Unknown

• 1 other identifier: 2021-02414
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Pre-Term

Keywords

music therapy; preterm infants; preterm parents; synchronization; hyperscanning; NIRS; HRV; oxyPrem

Outcome Measures

Primary Outcomes (1)

• 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).

  50 minutes

Study Arms (1)

Creative Music Therapy

EXPERIMENTAL

20 minutes of infant-directed singing in lullaby-style accompanied with the monochord for preterm infant and parent during kangaroo-care

Other: Creative Music Therapy

Interventions

Creative Music Therapy OTHER

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.

Creative Music Therapy

Eligibility Criteria

• Age: 32 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• admission for palliative care
• congenital malformation
• parental psychiatric disorders
• parental language barriers

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Dirk Bassler, Prof.

  University Hospital Zurich, Department Neonatology

  STUDY DIRECTOR

Central Study Contacts

Friederike Haslbeck, PhD

CONTACT

+41 78 708 1862; friederike.haslbeck@usz.ch

Felix Scholkmann, PD, PhD

CONTACT

+41 44 255 53 45; felix.scholkmann@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The intervention can not be masked since it is provided with live music to the infants and parents.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One single group will be included with a pre-during-post intervention design.

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 20, 2022
• Study Start: November 3, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)