A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants

Conditions
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SGA, Prematurity, Sepsis, RDS

Intervention / Treatment
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* Other: Music Intervention
* Other: Music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premature infants diagnosed with SGA, RDS and/or Sepsis >32 weeks Referred by Neonatologist IRB HIPPA Informed Parent for infant consent obtained in writing Exclusion Criteria: Infants with diagnoses other than the above

Ages Eligible for Study
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Minimum Age: 32 Weeks
Maximum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Music intervention- SGA<br>Infants will be randomly assigned to receive one of three music interventions randomized for the AM or PM | Other: Music Intervention<br>* Applied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies<br>Other: Music<br>* Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'<br>* Other names: Music therapist's or Parent's preferred lullaby or 'Twinkle';|
| Active Comparator: Music Intervention- RDS<br>Infants will be randomly assigned to receive music-one of 3 randomized interventions in the AM or PM | Other: Music Intervention<br>* Applied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies<br>Other: Music<br>* Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'<br>* Other names: Music therapist's or Parent's preferred lullaby or 'Twinkle';|
| Active Comparator: Music Intervention- Sepsis<br>Infants randomly assigned to receive one of three interventions-randomized for the AM or PM | Other: Music Intervention<br>* Applied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies<br>Other: Music<br>* Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'<br>* Other names: Music therapist's or Parent's preferred lullaby or 'Twinkle';|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | over two weeks intervention periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitals | The HR, RR, O2sats, activity level, sleep. feeds and parental stress will be measured | 10 mins before, during and after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music therapy, entrainment, premature infants, live music intervention, parent preferred lullabies