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A 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
Beth Israel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

32 Weeks - 40 Weeks (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 16, 2012
    Last Updated
    March 19, 2015
    Sponsor
    Beth Israel Medical Center
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    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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