NCT03689725

Brief Summary

Studying the effect of music intervention on preterm infants' brain development by MRI and neurodevelopmental assessments

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 1, 2013

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

11.8 years

First QC Date

August 28, 2018

Last Update Submit

April 10, 2024

Conditions

Prematurity

Outcome Measures

Primary Outcomes (2)

  • Compare structural maturation in the three groups using structural MRI and DTI

    An MRI will be conducted at term or term equivalent age including structural Magnetic Resonance Imaging and Diffusion Tensor Imaging (DTI) measures.

    40 weeks gestational age

  • Compare resting state maturation in the three groups using resting state fMRI

    An MRI will be conducted at term or term equivalent age including resting state functional magnetic resonance imaging (fMRI) measures.

    40 weeks gestational age

Secondary Outcomes (5)

  • Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using fMRI

    40 weeks gestational age

  • Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using EEG

    40 weeks gestational age

  • The music intervention effect on cognitive language and motor development at one and two years of age

    at 1 and 2 years of age

  • The music intervention effect on emotion and temperament at one and two years of age

    at 1 and 2 years of age

  • The music intervention effect on effortful control at one and two years of age

    at 2 years of age

Study Arms (3)

Preterm music group

EXPERIMENTAL

Music exposure with headphones

Other: Music

Preterm control group

NO INTERVENTION

headphones without music

Full-term control group

NO INTERVENTION

Interventions

MusicOTHER

Music created by A. Vollenweider at least 5 times per week from 33 weeks of gestational age until term-equivalent age

Preterm music group

Eligibility Criteria

Age33 Weeks - 42 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants: 33 weeks \< gestational age \< 37 weeks
  • Full-term newborns: 37 weeks gestational age \< 42 weeks

You may not qualify if:

  • Neurological issues or malformations (such as III-IV stade Intraventricular hemorrhage, micro or macrocephaly, hydrocephaly...)
  • Because of the high noise caused by nasal continuous positive airway pressure (nCPAP), preterm newborns without at least nCPAP pause before 32 6/7 gestational age will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Petra S. Hüppi

Geneva, 1211, Switzerland

RECRUITING

Related Publications (1)

  • Sa de Almeida J, Baud O, Fau S, Barcos-Munoz F, Courvoisier S, Lordier L, Lazeyras F, Huppi PS. Music impacts brain cortical microstructural maturation in very preterm infants: A longitudinal diffusion MR imaging study. Dev Cogn Neurosci. 2023 Jun;61:101254. doi: 10.1016/j.dcn.2023.101254. Epub 2023 May 11.

    PMID: 37182337DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Obstetric 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

Central Study Contacts

Petra S. Hüppi, Prof.

CONTACT

0223824352petra.huppi@hcuge.ch

Lara Lordier, PhD

CONTACT

0223725494lara.lordier@hcuge.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2018

First Posted

September 28, 2018

Study Start

March 1, 2013

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations

CH(1)