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Completed

NCT Number: NCT01908244

Short-term Effects of Live Music in Preterm Infants

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

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

26 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Filderklinik, Filderstadt, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Music

Other

Pentatonic music

Primary outcomes

  1. Numbers of desaturations < 90% per hour

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Collaborators

  • University Hospital Tuebingen

Registry information

Official study title

Short-term Effects of Live Pentatonic Music on Physiological Parameters in Preterm Infants - A Randomized Controlled Trial With Crossover Design

Acronym: MTN05

Important dates

Study start
2013
Primary completion
2013
First posted
Jul 25, 2013
Registry last updated
Oct 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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