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Short-term Effects of Live Music in Preterm Infants (MTN05)

Primary Purpose

Prematurity

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Music
Sponsored by
ARCIM Institute Academic Research in Complementary and Integrative Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prematurity focused on measuring Preterm infants, music, Neonatal Intensive Care Unit (NICU)

Eligibility Criteria

26 Weeks - 34 Weeks (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Filderklinik
  • Universtitätsklinikum für Kinder und Jugendmedizin, Abteilung IV Neonatologie

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Music

Arm Description

No pentatonic music

Outcomes

Primary Outcome Measures

Numbers of desaturations < 90% per hour

Secondary Outcome Measures

DI < 85% (Desaturations <85%/hour)
DI < 80% (Desaturations <80% per hour)
Heart rate
Oxygen saturation
Apnoea > 4 sec /h
Bradycardia < 80 bpm/h
Tachycardia > 200 bmp/h
HRV-Parameters
SDNN, RMSSD, pNN50, LF/HF
PI
Perfusionindex
PTT
Pulse-Transit-Time (ms)
State Trait Anxiety Inventory
State of the child
additional music questions

Full Information

First Posted
July 23, 2013
Last Updated
October 22, 2013
Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Collaborators
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT01908244
Brief Title
Short-term Effects of Live Music in Preterm Infants
Acronym
MTN05
Official Title
Short-term Effects of Live Pentatonic Music on Physiological Parameters in Preterm Infants - A Randomized Controlled Trial With Crossover Design
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Collaborators
University Hospital Tuebingen

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
Preterm infants, music, Neonatal Intensive Care Unit (NICU)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No pentatonic music
Arm Title
Music
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
Pentatonic music
Primary Outcome Measure Information:
Title
Numbers of desaturations < 90% per hour
Time Frame
physiological parameters are measured twice over a period of 2 hours and 15 minutes
Secondary Outcome Measure Information:
Title
DI < 85% (Desaturations <85%/hour)
Time Frame
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Title
DI < 80% (Desaturations <80% per hour)
Time Frame
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Title
Heart rate
Time Frame
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Title
Oxygen saturation
Time Frame
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Title
Apnoea > 4 sec /h
Time Frame
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Title
Bradycardia < 80 bpm/h
Time Frame
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Title
Tachycardia > 200 bmp/h
Time Frame
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Title
HRV-Parameters
Description
SDNN, RMSSD, pNN50, LF/HF
Time Frame
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Title
PI
Description
Perfusionindex
Time Frame
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Title
PTT
Description
Pulse-Transit-Time (ms)
Time Frame
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Title
State Trait Anxiety Inventory
Time Frame
If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
Title
State of the child
Time Frame
If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
Title
additional music questions
Time Frame
If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Filderklinik
City
Filderstadt
State/Province
Baden-Württemberg
ZIP/Postal Code
70794
Country
Germany
Facility Name
Universtitätsklinikum für Kinder und Jugendmedizin, Abteilung IV Neonatologie
City
Tuebingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16732778
Citation
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.
Results Reference
background
PubMed Identifier
12029604
Citation
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.
Results Reference
background

Learn more about this trial

Short-term Effects of Live Music in Preterm Infants

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