NCT01908244

Brief Summary

The purpose of this study is to determine the effects of pentatonic live music on physiological parameters in preterm infants.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

July 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Last Updated

October 23, 2013

Status Verified

July 1, 2013

Enrollment Period

3 months

First QC Date

July 23, 2013

Last Update Submit

October 22, 2013

Conditions

Prematurity

Keywords

Preterm infants, music, Neonatal Intensive Care Unit (NICU)

Outcome Measures

Primary Outcomes (1)

  • Numbers of desaturations < 90% per hour

    physiological parameters are measured twice over a period of 2 hours and 15 minutes

Secondary Outcomes (13)

  • DI < 85% (Desaturations <85%/hour)

    Physiological parameters are measured twice over a period of 2 hours and 15 minutes.

  • DI < 80% (Desaturations <80% per hour)

    Physiological parameters are measured twice over a period of 2 hours and 15 minutes.

  • Heart rate

    Physiological parameters are measured twice over a period of 2 hours and 15 minutes.

  • Oxygen saturation

    Physiological parameters are measured twice over a period of 2 hours and 15 minutes.

  • Apnoea > 4 sec /h

    Physiological parameters are measured twice over a period of 2 hours and 15 minutes.

  • +8 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

No pentatonic music

Music

EXPERIMENTAL
Other: Music

Interventions

MusicOTHER

Pentatonic music

Music

Eligibility Criteria

Age26 Weeks - 34 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age 26-34 weeks; no use of CPAP (Continous Positive Airway Pressure) or any other form of mechanical ventilation; signed informed consent of the parents

You may not qualify if:

  • Heart defect or known cardiac arrhythmia; other diseases of the preterm and newborn period (including infections and chromosomal aberrations) which make an additional diagnostic and therapeutic intervention unacceptable; detection of deafness (TEOAE, transitory evoked otoacoustic emission)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

Universtitätsklinikum für Kinder und Jugendmedizin, Abteilung IV Neonatologie

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (2)

  • Arnon S, Shapsa A, Forman L, Regev R, Bauer S, Litmanovitz I, Dolfin T. Live music is beneficial to preterm infants in the neonatal intensive care unit environment. Birth. 2006 Jun;33(2):131-6. doi: 10.1111/j.0730-7659.2006.00090.x.

    PMID: 16732778BACKGROUND

  • Standley JM. A meta-analysis of the efficacy of music therapy for premature infants. J Pediatr Nurs. 2002 Apr;17(2):107-13. doi: 10.1053/jpdn.2002.124128.

    PMID: 12029604BACKGROUND

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

Study Design

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

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 25, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2013

Last Updated

October 23, 2013

Record last verified: 2013-07

Locations

DE(2)