Clinical trial NCT01908244: Short-term Effects of Live Music in Preterm Infants
Official title: Short-term Effects of Live Pentatonic Music on Physiological Parameters in Preterm Infants - A Randomized Controlled Trial With Crossover Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Keywords: Preterm infants, music, Neonatal Intensive Care Unit (NICU)
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2013-07-25
Enrollment: 21
Sex: ALL
Minimum age (years): 26
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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


Eligibility 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)

Primary outcomes:
measure: Numbers of desaturations < 90% per hour
timeFrame: physiological parameters are measured twice over a period of 2 hours and 15 minutes
Secondary outcomes:
measure: DI < 85% (Desaturations <85%/hour)
timeFrame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
measure: DI < 80% (Desaturations <80% per hour)
timeFrame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
measure: Heart rate
timeFrame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
measure: Oxygen saturation
timeFrame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
measure: Apnoea > 4 sec /h
timeFrame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
measure: Bradycardia < 80 bpm/h
timeFrame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
measure: Tachycardia > 200 bmp/h
timeFrame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
measure: HRV-Parameters
timeFrame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
measure: PI
timeFrame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
measure: PTT
timeFrame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
measure: State Trait Anxiety Inventory
timeFrame: If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
measure: State of the child
timeFrame: If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
measure: additional music questions
timeFrame: If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Filderklinik
state: Baden-Württemberg
city: Tuebingen
country: Germany
facility: Universtitätsklinikum für Kinder und Jugendmedizin, Abteilung IV Neonatologie
state: Baden-Württemberg
Study officials:
References:
citation: Arnon S, Shapsa A, Forman L, Regev R, Bauer S, Litmanovitz I, Dolfin T. Live music is beneficial to preterm infants in the neonatal intensive care unit environment. Birth. 2006 Jun;33(2):131-6. doi: 10.1111/j.0730-7659.2006.00090.x.
citation: Standley JM. A meta-analysis of the efficacy of music therapy for premature infants. J Pediatr Nurs. 2002 Apr;17(2):107-13. doi: 10.1053/jpdn.2002.124128.