Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01908244
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : October 23, 2013
Sponsor:
Collaborator:
University Hospital Tuebingen
Information provided by (Responsible Party):
ARCIM Institute Academic Research in Complementary and Integrative Medicine

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

Condition or disease Intervention/treatment Phase
Prematurity Other: Music Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Short-term Effects of Live Pentatonic Music on Physiological Parameters in Preterm Infants - A Randomized Controlled Trial With Crossover Design
Study Start Date : July 2013
Actual Primary Completion Date : October 2013

Arm Intervention/treatment
No Intervention: Control
No pentatonic music
Experimental: Music Other: Music
Pentatonic music




Primary Outcome Measures :
  1. Numbers of desaturations < 90% per hour [ Time Frame: physiological parameters are measured twice over a period of 2 hours and 15 minutes ]

Secondary Outcome Measures :
  1. DI < 85% (Desaturations <85%/hour) [ Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes. ]
  2. DI < 80% (Desaturations <80% per hour) [ Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes. ]
  3. Heart rate [ Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes. ]
  4. Oxygen saturation [ Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes. ]
  5. Apnoea > 4 sec /h [ Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes. ]
  6. Bradycardia < 80 bpm/h [ Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes. ]
  7. Tachycardia > 200 bmp/h [ Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes. ]
  8. HRV-Parameters [ Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes. ]
    SDNN, RMSSD, pNN50, LF/HF

  9. PI [ Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes. ]
    Perfusionindex

  10. PTT [ Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes. ]
    Pulse-Transit-Time (ms)

  11. 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 ]
  12. 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 ]
  13. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   26 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908244


Locations
Layout table for location information
Germany
Filderklinik
Filderstadt, Baden-Württemberg, Germany, 70794
Universtitätsklinikum für Kinder und Jugendmedizin, Abteilung IV Neonatologie
Tuebingen, Baden-Württemberg, Germany, 72076
Sponsors and Collaborators
ARCIM Institute Academic Research in Complementary and Integrative Medicine
University Hospital Tuebingen

Publications:
Layout table for additonal information
Responsible Party: ARCIM Institute Academic Research in Complementary and Integrative Medicine
ClinicalTrials.gov Identifier: NCT01908244     History of Changes
Other Study ID Numbers: ARCIM_MTN05
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: July 2013

Keywords provided by ARCIM Institute Academic Research in Complementary and Integrative Medicine:
Preterm infants, music, Neonatal Intensive Care Unit (NICU)