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Short-term Effects of Live Music in Preterm Infants

NCT ID: NCT01908244

Last Updated: 2013-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Brief Summary

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

Detailed Description

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Conditions

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Prematurity

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

No pentatonic music

Group Type NO_INTERVENTION

No interventions assigned to this group

Music

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

Pentatonic music

Interventions

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Music

Pentatonic music

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

26 Weeks

Maximum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role collaborator

ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Filderklinik

Filderstadt, Baden-Wurttemberg, Germany

Site Status

Universtitätsklinikum für Kinder und Jugendmedizin, Abteilung IV Neonatologie

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 16732778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12029604 (View on PubMed)

Other Identifiers

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ARCIM_MTN05

Identifier Type: -

Identifier Source: org_study_id