Short-term Effects of Live Music in Preterm Infants

Not Applicable

Completed

• Conditions: Prematurity
• Interventions: Other: Music

• Registration Number: NCT01908244
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-07
• Study Start: 2013-07
• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-25
• Primary Completion: 2013-10
• Last Update Submitted: 2013-10-22
• Last Update Posted: 2013-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Music	Music	-

Primary Outcome Measures

Name	Time	Method
Numbers of desaturations < 90% per hour	physiological parameters are measured twice over a period of 2 hours and 15 minutes

Secondary Outcome Measures

Name	Time	Method
DI < 85% (Desaturations <85%/hour)	Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Tachycardia > 200 bmp/h	Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
PI	Physiological parameters are measured twice over a period of 2 hours and 15 minutes.	Perfusionindex
State Trait Anxiety Inventory	If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
additional music questions	If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
DI < 80% (Desaturations <80% per hour)	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.
Bradycardia < 80 bpm/h	Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
HRV-Parameters	Physiological parameters are measured twice over a period of 2 hours and 15 minutes.	SDNN, RMSSD, pNN50, LF/HF
State of the child	If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
Heart rate	Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
PTT	Physiological parameters are measured twice over a period of 2 hours and 15 minutes.	Pulse-Transit-Time (ms)

Trial Locations

Locations (2)

Universtitätsklinikum für Kinder und Jugendmedizin, Abteilung IV Neonatologie; 🇩🇪 Tuebingen, Baden-Württemberg, Germany

Filderklinik; 🇩🇪 Filderstadt, Baden-Württemberg, Germany