Short-term Effects of Live Music in Preterm Infants

Study Overview
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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.

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

Conditions
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Prematurity

Intervention / Treatment
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* Other: Music


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 26 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No pentatonic music | |
| Experimental: Music<br> | Other: Music<br>* Pentatonic music<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of desaturations < 90% per hour |  | physiological parameters are measured twice over a period of 2 hours and 15 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm infants, music, Neonatal Intensive Care Unit (NICU)