PrematurityMTN05NCT01908244
Short-term Effects of Live Music in Preterm Infants
A study testing Music in people with Prematurity, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 2 sites in Germany.
Trial summary
The purpose of this study is to determine the effects of pentatonic live music on physiological parameters in preterm infants. Read more about this study
- Who is it for?
- Ages 26 to 34 weeks
- Conditions the study is for
- Prematurity
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Filderklinik
Filderstadt, Baden-Wurttemberg, 70794
Universtitätsklinikum für Kinder und Jugendmedizin, Abteilung IV Neonatologie
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Short-term Effects of Live Pentatonic Music on Physiological Parameters in Preterm Infants - A Randomized Controlled Trial With Crossover Design
The purpose of this study is to determine the effects of pentatonic live music on physiological parameters in preterm infants.
- Conditions
- Prematurity
- Being tested
- Music
- Keywords
- Preterm infants, music, Neonatal Intensive Care Unit (NICU)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Pentatonic music
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No pentatonic music |
| Music | Experimental | Not described Receives: Other: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of desaturations < 90% per hour
Measured: physiological parameters are measured twice over a period of 2 hours and 15 minutes
Secondary outcomes (13)
DI < 85% (Desaturations <85%/hour)
Measured: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
DI < 80% (Desaturations <80% per hour)
Measured: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Heart rate
Measured: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Oxygen saturation
Measured: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Apnoea > 4 sec /h
Measured: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Bradycardia < 80 bpm/h
Measured: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Tachycardia > 200 bmp/h
Measured: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
HRV-Parameters
SDNN, RMSSD, pNN50, LF/HF
Measured: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
PI
Perfusionindex
Measured: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
PTT
Pulse-Transit-Time (ms)
Measured: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
State Trait Anxiety Inventory
Measured: If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
State of the child
Measured: If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
additional music questions
Measured: If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908244
- Sponsor's protocol ID
- ARCIM_MTN05
- Acronym
- MTN05
- Status last verified
- Jul 2013
- First submitted
- 23 Jul 2013
- Last updated
- 23 Oct 2013
- Results posted
- No
Publications
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.
PubMed 16732778Standley 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.
PubMed 12029604
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Live Pentatonic Music on Physiological Parameters in Preterm Infants - A Randomized Controlled Trial With Crossover Design
- ClinicalTrials.gov ID
- NCT01908244
- Acronym / sponsor ID
- MTN05 / ARCIM_MTN05
- Conditions
- Prematurity
- Keywords
- Preterm infants, music, Neonatal Intensive Care Unit (NICU)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- Jul 2013
- Primary completion
- Oct 2013 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of pentatonic live music on physiological parameters in preterm infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No pentatonic music |
| Music | Experimental | Other: Music |
Who may qualify
- Ages
- 26 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicPentatonic music | Other | Music |
Primary outcome
Numbers of desaturations < 90% per hour
Time frame: physiological parameters are measured twice over a period of 2 hours and 15 minutes
13 secondary outcomes
DI < 85% (Desaturations <85%/hour)
Time frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
DI < 80% (Desaturations <80% per hour)
Time frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Heart rate
Time frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Oxygen saturation
Time frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Apnoea > 4 sec /h
Time frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Bradycardia < 80 bpm/h
Time frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Tachycardia > 200 bmp/h
Time frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
HRV-Parameters
Time frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
PI
Time frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
PTT
Time frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2013.
- Background: PubMed 16732778Arnon 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.
- Background: PubMed 12029604Standley 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.
Related trials for Prematurity
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Recruiting
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NEC - Necrotizing Enterocolitis
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Prematurity, run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of desaturations < 90% per hour (time frame: physiological parameters are measured twice over a period of 2 hours and 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01908244, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2013.