NCT02434224

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

4 years

First QC Date

March 30, 2015

Last Update Submit

February 4, 2019

Conditions

Developmental Delay (Disorder)

Keywords

Music therapypremature infantbrain development

Outcome Measures

Primary Outcomes (1)

  • Brain volume

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

    40 gestational weeks

Secondary Outcomes (2)

  • Mental Development Index (Bayley III)

    24 months corrected for prematurity

  • Intelligence Quotient

    5 years

Study Arms (2)

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.

Procedure: Music Therapy

control

NO INTERVENTION

standard care

Interventions

Music TherapyPROCEDURE

2 to 3 sessions per week of individualized creative music therapy

music therapy

Eligibility Criteria

Age7 Days - 14 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Zurich, 8091, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 34222141DERIVED

  • 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.

    PMID: 28975039DERIVED

MeSH Terms

Conditions

Developmental DisabilitiesPremature Birth

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hans U Bucher, Prof.

    University of Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2015

First Posted

May 5, 2015

Study Start

January 1, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

CH(1)