Back to resultsA Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants
Primary Purpose
Prematurity, Sepsis, SGA
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Music Intervention
Music
Sponsored by
About this trial
This is an interventional supportive care trial for Prematurity focused on measuring music therapy, entrainment, premature infants, live music intervention, parent preferred lullabies
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Music intervention- SGA
Music Intervention- RDS
Music Intervention- Sepsis
Arm Description
Infants will be randomly assigned to receive one of three music interventions randomized for the AM or PM
Infants will be randomly assigned to receive music-one of 3 randomized interventions in the AM or PM
Infants randomly assigned to receive one of three interventions-randomized for the AM or PM
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Vitals
The HR, RR, O2sats, activity level, sleep. feeds and parental stress will be measured
Full Information
NCT ID
NCT01511952
First Posted
January 16, 2012
Last Updated
March 19, 2015
Sponsor
Beth Israel Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01511952
Brief Title
A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants
Official Title
A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Sepsis, SGA, RDS
Keywords
music therapy, entrainment, premature infants, live music intervention, parent preferred lullabies
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
272 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music intervention- SGA
Arm Type
Active Comparator
Arm Description
Infants will be randomly assigned to receive one of three music interventions randomized for the AM or PM
Arm Title
Music Intervention- RDS
Arm Type
Active Comparator
Arm Description
Infants will be randomly assigned to receive music-one of 3 randomized interventions in the AM or PM
Arm Title
Music Intervention- Sepsis
Arm Type
Active Comparator
Arm Description
Infants randomly assigned to receive one of three interventions-randomized for the AM or PM
Intervention Type
Other
Intervention Name(s)
Music Intervention
Intervention Description
Applied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies
Intervention Type
Other
Intervention Name(s)
Music
Other Intervention Name(s)
Remo Ocean disc, Gato box, Music therapist's or Parent's preferred lullaby or 'Twinkle'
Intervention Description
Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'
Primary Outcome Measure Information:
Title
The effects of live music intervention on premature baby function
Description
Infants function according to flow sheet and in cumulative administration will be viewed with and without music therapy entrainment
Time Frame
over two weeks intervention periods
Secondary Outcome Measure Information:
Title
Vitals
Description
The HR, RR, O2sats, activity level, sleep. feeds and parental stress will be measured
Time Frame
10 mins before, during and after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
40 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne V Loewy, DA, MT-BC, LCAT
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Multi-Site Study of Music Therapy Interventions on Vitals, Feeding and Sleep in Premature Infants
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