Prematurity
Conditions
Keywords
Preterm infants, music, Neonatal Intensive Care Unit (NICU)
Brief summary
The purpose of this study is to determine the effects of pentatonic live music on physiological parameters in preterm infants.
Interventions
OTHERMusic
Pentatonic music
Sponsors
University Hospital Tuebingen
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
26 Weeks to 34 Weeks
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numbers of desaturations < 90% per hour | physiological parameters are measured twice over a period of 2 hours and 15 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
| PI | Physiological parameters are measured twice over a period of 2 hours and 15 minutes. | Perfusionindex |
| HRV-Parameters | Physiological parameters are measured twice over a period of 2 hours and 15 minutes. | SDNN, RMSSD, pNN50, LF/HF |
| PTT | Physiological parameters are measured twice over a period of 2 hours and 15 minutes. | Pulse-Transit-Time (ms) |
| 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 | — |
| Tachycardia > 200 bmp/h | Physiological parameters are measured twice over a period of 2 hours and 15 minutes. | — |
Countries
Germany
Outcome results
None listed