PrematurityNCT01511952
A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants
A study testing Music Intervention and Music in people with Prematurity and Sepsis, run by Beth Israel Medical Center.
Trial summary
This is a multi-site study of 272 premature infants >32 weeks who served in a randomized investigation (in morning or afternoon) where they served as their own controls. The infants' HR, RR, O2sats were measured with and without the implementation fo live music. Read more about this study
- Who is it for?
- Ages 32 to 40 weeks
- Conditions the study is for
- Prematurity, Sepsis, SGA
- What is being tested?
- Music Intervention and Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Dec 2010
- 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 32 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature infants diagnosed with SGA, RDS and/or Sepsis >32 weeks Referred by Neonatologist IRB HIPPA Informed Parent for infant consent obtained in writing
Who cannot join
- Infants with diagnoses other than the above
About this study
This is a multi-site study of 272 premature infants >32 weeks who served in a randomized investigation (in morning or afternoon) where they served as their own controls. The infants' HR, RR, O2sats were measured with and without the implementation fo live music. The live interventions included songs of kin, selected by parents, the gato box and ocean disc played through entrained methods by a music therapist. The infants were evaluated within a two week period and in total each day including feeds, voids, activity level and sleep.
- Conditions
- Prematurity, Sepsis, SGA, RDS
- Being tested
- Music Intervention, Music
- Keywords
- music therapy, entrainment, premature infants, live music intervention, parent preferred lullabies
- Medical subject headings
- Premature Birth, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music InterventionOther
Applied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies
MusicOther
Also called Remo Ocean disc, Gato box, Music therapist's or Parent's preferred lullaby or 'Twinkle'
Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'
| Study group | Role | What they receive |
|---|---|---|
| Music intervention- SGA | Active comparator | Infants will be randomly assigned to receive one of three music interventions randomized for the AM or PM Receives: Other: Music Intervention; Other: Music |
| Music Intervention- RDS | Active comparator | Infants will be randomly assigned to receive music-one of 3 randomized interventions in the AM or PM Receives: Other: Music Intervention; Other: Music |
| Music Intervention- Sepsis | Active comparator | Infants randomly assigned to receive one of three interventions-randomized for the AM or PM Receives: Other: Music Intervention; Other: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of live music intervention on premature baby function
Infants function according to flow sheet and in cumulative administration will be viewed with and without music therapy entrainment
Measured: over two weeks intervention periods
Secondary outcomes (1)
Vitals
The HR, RR, O2sats, activity level, sleep. feeds and parental stress will be measured
Measured: 10 mins before, during and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJan 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne V Loewy, DA, MT-BC, LCAT, Principal investigator, Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511952
- Sponsor's protocol ID
- NICU Music Tx Interventions
- Status last verified
- Mar 2015
- First submitted
- 16 Jan 2012
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants
- ClinicalTrials.gov ID
- NCT01511952
- Acronym / sponsor ID
- NICU Music Tx Interventions
- Conditions
- Prematurity, Sepsis, SGA, RDS
- Keywords
- music therapy, entrainment, premature infants, live music intervention, parent preferred lullabies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Jan 2012 (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.
This is a multi-site study of 272 premature infants >32 weeks who served in a randomized investigation (in morning or afternoon) where they served as their own controls. The infants' HR, RR, O2sats were measured with and without the implementation fo live music. The live interventions included songs of kin, selected by parents, the gato box and ocean disc played through entrained methods by a music therapist. The infants were evaluated within a two week period and in total each day including feeds, voids, activity level and sleep.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music intervention- SGA | Active comparator | Other: Music Intervention, Other: MusicInfants will be randomly assigned to receive one of three music interventions randomized for the AM or PM |
| Music Intervention- RDS | Active comparator | Other: Music Intervention, Other: MusicInfants will be randomly assigned to receive music-one of 3 randomized interventions in the AM or PM |
| Music Intervention- Sepsis | Active comparator | Other: Music Intervention, Other: MusicInfants randomly assigned to receive one of three interventions-randomized for the AM or PM |
Who may qualify
- Ages
- 32 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature infants diagnosed with SGA, RDS and/or Sepsis >32 weeks Referred by Neonatologist IRB HIPPA Informed Parent for infant consent obtained in writing
Key exclusion criteria (1 listed)
- Infants with diagnoses other than the above
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 |
|---|---|---|
| Music InterventionApplied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies | Other | Music Intervention- RDS, Music Intervention- Sepsis, Music intervention- SGA |
| MusicAlso: Remo Ocean disc, Gato box, Music therapist's or Parent's preferred lullaby or 'Twinkle'Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle' | Other | Music Intervention- RDS, Music Intervention- Sepsis, Music intervention- SGA |
Primary outcome
The effects of live music intervention on premature baby function
Time frame: over two weeks intervention periods
Infants function according to flow sheet and in cumulative administration will be viewed with and without music therapy entrainment
1 secondary outcome
Vitals
Time frame: 10 mins before, during and after 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 24 Mar 2015.
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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.
Joanne V Loewy, DA, MT-BC, LCAT principal investigator
Beth Israel Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Music Intervention and Music in people with Prematurity and Sepsis, run by Beth Israel Medical Center.
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 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The effects of live music intervention on premature baby function (time frame: over two weeks intervention periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2015.